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U.S. Department of Health and Human Services

Class 2 Device Recall SynchroMed II implantable drug infusion pump

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 Class 2 Device Recall SynchroMed II implantable drug infusion pumpsee related information
Date Initiated by FirmFebruary 09, 2017
Create DateMarch 29, 2017
Recall Status1 Terminated 3 on September 04, 2018
Recall NumberZ-1694-2017
Recall Event ID 76591
PMA NumberP860004S056 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductSynchroMed II implantable drug infusion pump, Model 8637-40,
Code Information Serial Number NGV526743H
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information ContactMedtronic Neuromodulation Technical Serv
800-707-0933
Manufacturer Reason
for Recall		Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
FDA Determined
Cause 2		Under Investigation by firm
ActionA Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol. Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933.
Quantity in Commerce1
DistributionIL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LKK
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