MULTI-PROGRAM NEUROSTIMULATORS AND ACCESSORIES (2015-07-22)

Starting date:

July 22, 2015

Posting date:

August 24, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54764

• Reason
• Affected products

Affected Products

A. KINETRA NEUROSTIMULATOR PULSE GENERATOR & ACCESSORY KIT

B. ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR

C. ACTIVA RC MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR

D. SOLETRA QUADRIPOLAR MULTI-PROGRAMMABLE NEUROSTIMULATOR

E. ACTIVA SC - NEUROSTIMULATOR

Reason

The purpose of this notification is to notify implanting and follow up physician of information that is being added to the warnings and adverse events sections of Medtronic’s deep brain stimulation (DBS) labeling. These labeling updates result from Medtronic’s ongoing monitoring of reported events, clinical trials and published literature. The labeling updates further clarify potential risks which have been reported with DBS therapy. Medtronic is sharing this information with physicians to help with management of current patients treated with DBS therapy. Additional warnings being added to the labeling: DBS therapy for dystonia: status Dystonicus - severe, life-threatening dystonia symptoms, including status Dystonicus (also known as dystonic crisis or dystonic storm), during ongoing or loss of DBS therapy may result in respiratory compromise and Rhabdomyolysis. In rare cases, Rhabdomyolysis may progress to multi-organ failure and death. Monitor patients receiving DBS therapy for these symptoms. Emphasize the importance of contacting the patient's physician if they experience increased severity of symptoms. DBS therapy for epilepsy: return of symptoms - cessation or reduction of stimulation may potentially lead to an increase in seizure frequency or severity. Symptoms may return with intensity greater than was experienced prior to system implant, including the potential for status epilepticus. Emphasize the importance of contacting the patient's physician if they experience worsening of seizure frequency or severity.it is also important that the patient or caregiver knows how to use the patient programmer in case the Neurostimulator is accidentally turned off. Additional adverse events being added to the labeling for all indications of DBS therapy: meningitis, encephalitis, or brain abscess resulting from infection involving the brain and/or central nervous system. Focal edema localized to the area around the lead immediate or delayed intracranial hemorrhage or cerebral infarction which could be symptomatic, or which could result in temporary or permanent neurological injury or death aseptic Intraparenchymal cyst formation around the distal lead tip

Affected products