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

Model Number 37601

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

The patient reported that about a year prior to date notified their device was turning on and off by itself on the left side.It was stated that the manufacturer representative (rep) fixed the issue.There were no related patient symptoms.The patient's indication for implant is essential tremor and movement disorders.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6361489
• MDR Text Key: 68425923
• Report Number: 3004209178-2017-04665
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• 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,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Date Device Manufactured: 12/03/2013
• 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