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

Model Number 37602

Device Problems No Device Output (1435); Improper or Incorrect Procedure or Method (2017); Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the obsessive compulsive disorder (ocd) patient¿s implantable neurostimulator (ins) ¿could no longer be activated¿ at the time of report.It was stated this was ¿probably because it had been drained too many times.¿ later, it was noted the patient ¿had not recharger for a long time¿ and that the ¿device went into overdischarge.¿ a physician mode recharge (pmr) was successfully used to reset the ins.The problem was ¿solved¿ with ¿no problems¿ after completion of the pmr.There was ¿no injury to the patient¿ and no patient harm or death due to the event.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

• 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: 4447681
• MDR Text Key: 18065118
• Report Number: 3007566237-2015-00186
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• 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: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2015
• 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