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

Model Number 37601

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that "not quite a year ago", the patients ins battery "got really hot and started burning" them when they were getting an mri bone scan.The patient mentioned that they were in the mri for "a good 45 minutes".The patient stated that they have prostate cancer and their new clinic wanted them to get an mri so they can see the prostate and were told the mri would last 45 minutes.The patient was told that medtronic recommends that dbs patients not be in a mri for over half an hour and to use 2 different time periods.The rep confirmed that this is correct and reviewed active scan time limits from the dbs mri guidelines.The patient requested a copy of the mri guidelines.The rep reviewed that it is a highly technical document and emailed the dbs mri guidelines as requested.The rep advised the patient to consult with their managing healthcare provider regarding any concerns prior to getting an mri.No further complications were reported.

• 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: 11577506
• MDR Text Key: 245925314
• Report Number: 3004209178-2021-05015
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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: 03/26/2021

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: 04/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 03/26/2021
• Date Device Manufactured: 10/23/2018
• 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: 77 YR