MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Use of Device Problem (1670); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was having difficulty recharging the ins.The patient reported that the first attempt at recharging worked well.The second attempt they had a little more trouble and since that time they have had difficulty getting the recharger to connect.The patient reports that the pocket area hurts currently and there is some swelling in the pocket area.The rep speculated that the ins may be flipped in the pocket.The patient wasn't aware of any change to the ins in the pocket and reported that they sleep on their side.The recharger connects for a few seconds, the recharger then disconnects, and then the patient moves the recharger around to try to find a location when the recharger will connect again.The patient is able to get the recharger to connect for very short intervals.The patient reported that the ins was 25% charged and they spend about 5 hours trying to charge the ins.The patient attempts to charge every day because of the relatively low battery level.The recharger would not connect to the handset.Technical services (tss) had the patient press and hold the power button on the recharger for 45 seconds and then attempt to connect to the recharger application again.Tss had the caller check the recharging speed it was set to level 2.Tss had the patient try to turn the sound off and that did not resolve the issue.The issue was not resolved through troubleshooting.The patient plans to follow up with the managing hcp to further evaluate the ins pocket.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported it was unknown if the implant was flipped and the cause of the recharging issue was unknown or if it resolved.The patient was going to meet with their physician related to the issue.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 14166590
• MDR Text Key: 289741192
• Report Number: 3004209178-2022-05044
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2022
• Date Device Manufactured: 01/24/2022
• 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: 50 YR
• Patient Sex: Female