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

Model Number 37601

Device Problem Electromagnetic Interference (1194)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/01/2019

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

It was reported that patient had an mri done and they turned therapy off, and when patient turned the therapy back on their symptoms came back a little more.Patient stated they will be having an mri and wanted to know if they should turn off their implantable neurostimulator (ins).It was recommended for patient to consult with the health care provider (hcp) regarding turning therapy off.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9749975
• MDR Text Key: 183133778
• Report Number: 3004209178-2020-04000
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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
• Report Date: 02/25/2020

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: 01/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 02/25/2020
• Date Device Manufactured: 08/09/2017
• 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: 69 YR