MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

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

Patient Problem Therapeutic Effects, Unexpected (2099)

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 consumer via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).The rep reported that three weeks ago, the patient noticed that their device was charging very quickly.The rep reported that the patient's ins typically took 30 minutes or longer to charge every day, but now was only taking 5-10 minutes.The rep reported the patient's ins was checked to see it was turned on and it was reported that there was no circle with a lightning bold on the patient programmer, indicating the ins was off.The rep reported it was unknown how the ins was turned off.The rep reported the battery had been charged.The rep reported walking the patient through turning the ins back on.The rep reported that the device being off was responsible for the ins charging more quickly than expected.The rep reported that the issue was considered resolved, the patient's ins was turned on and the patient was reported to be feeling ok.The rep reported the following diary usage on the clinician programmer: on (b)(6) - only black box, no square around the dates (b)(6) - little bar black, turned off that day.Low battery legend was seen (b)(6) - normal.Group all box, no battery column.On (b)(6) - blank, nothing seen.On (b)(6) - blank, nothing seen.On (b)(6) - only square box around the dates (b)(6)- square box around the date, half black boxes (b)(6) - no square box on date, black bar seen.The caller reported that the last session date was (b)(6) 2018 and the therapy was on at 30%.The rep also reported seeing the observation screen, charge soon and check clock.No patient symptoms were reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep and confirmed by the hcp.It was determined the patient didn't notice their device was off.The battery was not properly charged by the nursing home staff and the ins went to zero and turned off.It was determined that the ins turned off on (b)(6) 2018 based on the logs after device interrogation.The issue has been resolved.No further complications were reported as a result of this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7611035
• MDR Text Key: 112170056
• Report Number: 3004209178-2018-13683
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• Date Device Manufactured: 10/09/2013
• 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