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

Model Number 37601

Device Problems Unintended Collision (1429); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The consumer reported that the patient turned the stimulation off shortly after it was implanted because "he just kind of gave up on setting it; he just could not be still and would practically fall out of his chair." the was doing better on medication than with the stimulator; he thrashed around when using the stimulator and "the doctor could never get it to work." the consumer thought the patient turned it off in 2012 and it was still implanted.There was no pain or issues with it still being implanted.The consumer also mentioned that the patient fell and broke his hip two and a half years ago, in 2012, and was now in a nursing home because of it.It was noted that the fall could be related to the event, but it was unclear based on the time frame.The patient's indication for use was movement disorders.It was unclear if the fall was related to the event and if any further interventions were performed, so additional information was requested.If additional information is received a supplemental report will be sent.

• 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: 5278793
• MDR Text Key: 33435413
• Report Number: 3004209178-2015-24106
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• 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: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2015
• Date Device Manufactured: 10/21/2010
• 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