MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Energy Output Problem (1431); Environmental Compatibility Problem (2929)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of the event: (b)(6) 2019 is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for parkinson's dual and movement disorders.It was reported that patient was suddenly feeling caps in their head and was wondering if it was normal.Patient stated that due to the severe cold they were experiencing caps in their head.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

The consumer said it was a user issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 8355788
• MDR Text Key: 136788881
• Report Number: 3004209178-2019-03639
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/17/2020
• Date Device Manufactured: 08/03/2016
• 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: 57 YR
• Patient Weight: 83