MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported the patient who was being treated for a ¿predominantly axial dystonic tremor¿ experienced ¿a shocking feeling down the left side of his body which seemed to be triggered particularly when he flexed his abdomen.¿ the patient had reportedly experienced the shocking condition ¿later on¿ after implant with no known associated falls or traumas.The patient¿s physician noted the implantable neurostimulator (ins) ¿was sited in the abdomen, so it was as if moving it induced the shocking feeling.¿ turning the patient¿s ins off resulted in a return of the patient¿s tremor symptoms; however the patient was unable to elicit the shocking feeling at that time.The possibility of an ins-extension connection issue was reported, though impedance testing of the patient¿s system returned ¿normal¿ measurements.The patient was reportedly ¿receiving effective therapy except for times when receiving the shocking sensation¿ at the time of report and was noted to be alive with no injury.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant: product id 37085-95, serial# (b)(4), implanted: 2012-(b)(6), product type extension.Product id 37085-95, serial# (b)(4), implanted: 2012-(b)(6), product type extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4078375
• MDR Text Key: 4858330
• Report Number: 9614453-2014-02056
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/10/2014
• Date Device Manufactured: 07/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00046 YR