MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Response, Decreased (2271); Cognitive Changes (2551)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical devices: product id: 37612, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.(b)(4).

Event Description

Information was received from a patient who was implanted with a neurostimulator for obsessive compulsive disorder (ocd).It was reported that the patient's rechargeable implantable neurostimulator (ins) turned off for a few days somehow; the patienthusband is in the hospital and he usually "does it" the patient is unsure why it keeps turning off and it has happened multiple times; she had to do a high dose because ocd was so bad.Troubleshooting resulted in the patient checking the status and it was off; the patient was able to turn the device back on.Additional information was received from the patient that indicated that her stimulation shut itself off again.She has been in and out of the nursing home for her husband staying there and is not sure if something there turned her device off.Additional information has been requested regarding the device identifiers, cause, and outcome, but it was not available at the time of this report.If additional information is received, a follow-up report will be submitted.Please see report number 3004209178-2016-03894.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 5480219
• MDR Text Key: 39872339
• Report Number: 3004209178-2016-03895
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Date Device Manufactured: 01/10/2013
• 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: 00063 YR