MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported the dystonia patient experienced a ¿shocking/jolting sensation¿ with both their implantable neurostimulator (ins) and their recharger.It was further reported the patient experienced ¿less than 50% therapy relief¿ with a ¿tremor over the arms and legs.¿ it was noted the patient was reprogrammed in an attempt to troubleshoot the situation.Impedance testing was performed and found impedances to be ¿ok.¿ the patient had not experienced any falls or traumas prior to report.Though the cause of the event had not been determined, it was noted the patient¿s physician thought ¿it could be a psychological event.¿ there were no further actions required at the time of initial report.Additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Product id: 37751, serial# (b)(4), product type: recharger.(b)(4).

Event Description

Additional information received reported the patient was shocked only by recharging the implantable neurostimulator (ins).The recharge statistics were checked and impedances were measured to be okay.The patient was okay and receiving effective therapy.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4639103
• MDR Text Key: 5597000
• Report Number: 3007566237-2015-00801
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2015
• 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