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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/22/2024

Event Type  malfunction  

Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins).  caller stated for some reason dbs just stopped working.Caller states patient is still shaking quite a bit and has not been able to speak.Patient services (pss) asked when this started and caller states almost immediate night and day it went from fine to uncontrollably.Patient has been trying to charge for almost an hour and the recharger is not doing anything to help the patients symptoms.Patient stated he has been able to charge today.During the call, caller states patient has full coupling bars, ins is charging between 50-75% but does not see lightening bolt ( ins off).When trying the second time, the caller stated the lightening bolt is now there and patients shaking is now calmer.Tremor is starting to diminish.Programmer at first showed poor communication but caller stated the programmer was not over the ins.When trying the second time the programmer showed therapy on/ok and about 50% charged.Caller mentioned patient had fallen and recently had ot and is wondering if that was related.Pss asked if the patient had let the ins charge level get too low but caller did not know.The troubleshooting steps that were taken on the call resolved the issue.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19205640
• MDR Text Key: 341514303
• Report Number: 3004209178-2024-09955
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2024
• Date Device Manufactured: 07/16/2014
• 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: 72 YR
• Patient Sex: Male