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

Model Number 37601

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Discomfort (2330); Neck Pain (2433)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.

Event 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
• 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: 11037526
• MDR Text Key: 226994220
• Report Number: 3004209178-2020-22220
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Date Device Manufactured: 07/12/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR