PRODUCT ADVISORIES DEEP BRAIN STIMULATION

Product Advisories

Medtronic is committed to providing you with the highest quality products and services and ongoing support.

As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.


2017

URGENT: MEDICAL DEVICE CORRECTION— MARCH 2017

DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE DEEP BRAIN STIMULATION (DBS) LEAD DEPTH STOP

Models Affected: Models 3387/3387S, 3389/3389S, and 3391/3391S DBS Lead Kits

Description:

This notification provides you important safety information regarding the use of the depth stop accessory provided in all Medtronic Deep Brain Stimulation (DBS) lead kits. The Medtronic DBS depth stop, otherwise referred to as the lead holder, is used to establish the implant depth. The depth stop interfaces with parts of the stereotactic system used during surgery to control placement of the DBS lead tip to the target location. Medtronic has received complaints from physicians reporting that the DBS depth stop did not adequately secure to the lead. This letter provides information regarding this product performance issue, potential risk to patients, and actions to take regarding use of the Medtronic depth stop.

If you do not use the Medtronic depth stop (for example, if you only use the FHC, Alpha Omega, or Nexdrive depth stop), you are not affected and no actions are needed.

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2016

URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016

DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE MODEL 37751 RECHARGER

Models Affected: Model 37751 Recharger, which is included in Model 37651 Charging System for DBS

Description:

This notification communicates important information regarding the issue of unresponsive and beeping Model 37751 Rechargers, and provides information on how to prevent occurrence of this issue and restore functionality of the Recharger if the issue occurs. Medtronic has identified an increased number of complaints from customers involving reports of Rechargers that that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. This Recharger is used by DBS patients who are implanted with a Medtronic Activa® RC (Model 37612) implantable neurostimulator.

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Urgent Medical Device Safety Notification – June 2016

Deep Brain Stimulation Therapy: Important Information Regarding Adaptor Handling During Implant Procedure

Models Affected: DBS Pocket Adaptor Models 64001 and 64002

Description:

This notification communicates recent results from returned product analysis of Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors with reports of high impedances, and reinforces device labeling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This applies to pocket adaptor Models 64001 and 64002 which can be used with the following implantable Neurostimulators: Activa™ PC (Model 37601) and Activa RC (Model 37612).

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Urgent Medical Device Safety Notification – May 2016

Deep Brain Stimulation Therapy: Reported Events Related to Loss of Coordination

Models Affected: 37612, 37601, 37602, 7428, 7426

Description:

This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. One report has been identified of an inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer. Physicians and patients should be aware that loss of coordination is identified in labeling as a potential side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood.

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Urgent Medical Device Safety Notification – May 2016

Deep Brain Stimulation Therapy: Reported Events Related to DBS Tunneling Procedure

Models Affected: 7483, 37086

Description:

This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. The following serious events or injuries are associated with the DBS implant and tunneling the extension from the lead to the INS:

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  • Cases of spinal accessory nerve injury
  • Severe bleeding or vascular injury
  • An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision
  • Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed

2015

Medical Device Safety Notification – April 2015

DBS Extension Handling During Implant Procedure

Description:

This notification reinforces device labeling specific to the handling of extensions and system integrity checking during implant procedures. 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).

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