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Class I Medical Device Recall: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Failure of Priming Bolus

Fri, 06/28/2013 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: June 3, 2013

Products: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps

  • SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
  • SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size)

This recall does not affect Medtronic external insulin pumps for diabetes.

These recalled products were from manufactured from May, 1998 through June, 2013 and distributed from April, 1999 through June, 2013.

Use: The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.

The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.

Recalling Firm:
Medtronic, Inc., Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568

Manufacturer:
Medtronic Puerto Rico Operations Co.
50 Road 31 km 24.4 Ceiba Norte Ind Park
Juncos, Puerto Rico 00777

Reason for Recall: The SynchroMed Implantable Infusion Pumps are being recalled because of the unintended delivery of drugs during the priming bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious medical illness such as respiratory depression, coma or death.

Public Contact: For questions about this recall, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.

FDA District: Minneapolis District Office

FDA Comments:
Patients:
Maintain regular follow-up appointments with your physicians. However, if you experience a change or return of symptoms or hear a device alarm, contact your physician immediately.

Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Correction letter.

On June 3, 2013, Medtronic sent an "Urgent: Medical Device Correction" disclaimer icon letter dated May 2013 to all affected customers. The letter described the background, nature of the issue, and provided recommendations for patient management and monitoring after introducing drugs into the spine (Intrathecal Therapy).

In its letter to health care providers, Medtronic recommended following published guidance for managing all patients with intrathecal therapy, in addition to the following:

  • Continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
  • Monitor all patients following start or restart of intrathecal therapy, as recommended below. The post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.
    • Opioids - For patients initiated or reinitiated with intrathecal infusion of opioids, monitoring with pulse oximetry for a minimum of 24 hours or until they demonstrate stable neurological, respiratory and cardiac function in a facility equipped with emergency airway management, oxygen, naloxone for treatment of opioid overdose and other emergency services is recommended. Please refer to additional instructions provided in the drug product labeling (including Infumorph®1) and published guidance.2
    • Baclofen – Patients initiating or reinitiating an intrathecal infusion of baclofen should be monitored in a facility that provides experienced nursing observation, with the ability and personnel for emergency airway management and ventilator support readily available. Patients should be monitored for a minimum of 8 hours or until they demonstrate stable neurological, respiratory and cardiac function.
    • Ziconotide – There are no labeling guidelines for patient monitoring after initiating or restarting ziconotide therapy.3 Published guidance recommends an overnight admission.2
  • Consider priming the pump prior to implant in the patient and before connection to the catheter (back table prime) to decrease the risk of overdose, especially in patients receiving higher concentration opioid drug solutions and low total daily dose.
  • Educate caregivers and family members to recognize the signs and symptoms associated with intrathecal drug therapy complications.2
  • Patients who are receiving intrathecal baclofen and who receive a catheter-only priming bolus with or without a CAP aspiration will take longer to reach full intended drug concentration. Dose titration may need to be supplemented with oral baclofen to treat spasticity until the optimal intrathecal dose is obtained.
  • Physicians should advise patients to avoid using concomitant drugs that may cause respiratory or CNS depression while intrathecal therapy is being initiated or resumed.

The firm is asking health care providers to return any explanted SynchroMed II implantable infusion pump to Medtronic Returned Products Analysis.

These actions are not expected to cause a device shortage.

Customers can contact their Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.


1Infumorph [package insert]. West-Ward Pharmaceuticals, Eatontown, NJ; September 2011. http://www.west-ward.com/images/files/package/Infumorph%20200&500%20PI.pdf. Accessed April 17, 2013.

2Deer, T. R., Prager, J., Levy, R., et. al. (2012), Polyanalgesic Consensus Conference—2012: Recommendations on Trialing for Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel. Neuromodulation: Technology at the Neural Interface, 15: 467–482.

3http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5449ca98-efb8-4c3b-8756-747b2349a472

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