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

Model Number	37601
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burning Sensation (2146); Discomfort (2330); Neck Pain (2433)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that about 2 weeks ago, the patient's right side implantable neurostimulator (ins) was bothering them, noting that the patient's neck was hurting.Yesterday, the patient "felt like it was burning inside where the battery is." they turned the patient's ins off and the patient no longer felt the burning sensation.They confirmed that the patient has not had any falls or trauma.They confirmed there is no issue with the ins on the patient's left side and it is currently turned on.They reported this issue to the patient's healthcare provider (hcp) and the hcp scheduled to have the ins replaced yesterday.Although the ins was scheduled to be replaced, the patient mentioned that the ins was never checked.The patient went to have the ins replaced, but they were told that the hcp was unable to replace the ins at this time due to covid-19 pandemic, so the appointment was rescheduled for (b)(6).They inquired about what the patient's options are in the meantime.They will contact a manufacturer representative (rep) to inquire if they can assist.The role of a rep was reviewed.

• Brand Name: ACTIVA
• Common Device Name: 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
• MDR Report Key: 11037526
• Report Number: 3004209178-2020-22220
• Device Sequence Number: 1046728
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR