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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Event date approximate.Month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinsonian tremor and movement disorders.It was reported the patient thought the patient programmer was not working.During the call the patient powered on the patient programmer and synced with the ins.The patient reported seeing the "ins battery low" screen on his patient programmer and clarified that this was the "patient programmer issue".During the call the patient used the ins recharger to start a charge session.The patient reported the 1//4 section was solid and the 2/4 section was flashing.The patient mentioned he had already charged for an hour and reported previously his stimulator battery "went out in the middle of the night" and clarified he noticed his therapy stopped by itself.The patient was instructed to continue charging and call back if he encountered the issue again.The patient called back later that day to verify that his ins was charged fully.During the call the patient connected the recharger and the patient stated he was seeing the ins battery charged at 1/2 with full coupling.The patient stated he had been charging his ins for 2 hours.It was reviewed with the patient it could take 4-6 hours to charge a completely empty ins battery.No further complications were reported or anticipated.Information regarding shocking in salt water can be found in pe#(b)(4).

• 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: 7586214
• MDR Text Key: 110585946
• Report Number: 3004209178-2018-13040
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 08/12/2015
• 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: 63 YR