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Medtronic DBS Extension Kit for Deep Brain Stimulation… recallZ-1617-2015 · Medtronic Neuromodulation · initiated Apr 16, 2015

Class II Terminated All recalls posted in May 2015

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 providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603).

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to [email protected]. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Recall details

Recall number
Z-1617-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 16, 2015
Posted by the FDA
May 15, 2015
Recalling firm
Medtronic Neuromodulation
Quantity
86,851 (US 37,933 / OUS 48,918)
Product code
MHY
FDA submissions
P960009
Distribution
worldwide

Product description

Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

Code information (models, lots, serial numbers)

all Serial numbers

Other devices under the same FDA submission

90 devices cleared under P960009 — 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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