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Medtronic SynchroMed II Implantable Drug Infusion System.… recallZ-0788-2017 · Medtronic Neuromodulation · initiated Oct 3, 2016

Class I Terminated All recalls posted in December 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 N Vision Clinician Programmer, with the updated version (new version is AAU01). Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Recall details

Recall number
Z-0788-2017
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Oct 3, 2016
Posted by the FDA
Dec 19, 2016
Recalling firm
Medtronic Neuromodulation
Quantity
22,298 software cards
Product code
LKK
FDA submissions
P860004
Distribution
Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.

Product description

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer

Code information (models, lots, serial numbers)

software application cards with versions other than AAU01

Other devices under the same FDA submission

51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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