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

Model Number 37612

Device Problems Delayed Charge Time (2586); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are:product id: wr9200, serial#: (b)(4), product type: recharger.Product id: a620, serial#: unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the wireless recharger (wr) was beeping continuously because it could not find their ins, and their handset indicated that there was no connection between the wr and handset.The patient mentioned that the wr would occasionally find the ins and stop beeping, but within 3 seconds it would lose connection and the wr would start beeping again.The patient stated that they reported this issue to a rep and the patient confirmed that the issue was eventually resolved and they could see on the recharger app that their ins was 25% charged.However, the patient stated that the issue resurfaced since then.The patient stated that they tried everything they could before calling patient services (which included taking the wr out of the drape), but the wr still could not find the ins.The patient mentioned that they still hand bandages over the ins site, but no swelling.During the call, the patient mentioned that they had the white side of the wr against their body, rather than the blue side.The wr made a connection to the ins for several seconds, but then it lost connection and started beeping continuously.It was at this time that the patient mentioned that they had put the wr in the drape, but the blue side of the wr was facing away from the ins.Once the patient had the wr inserted in the drape properly and had it positioned over their ins, the wr maintained a connection with the ins for the remainder of the call.However, the patient mentioned that the handset was showing a 'not found ¿ communicator' error message.They reviewed that the patient was in the incorrect app.The patient exited the dbs therapy app and opened the recharger app, but then they saw the following error message: 'recharger stopped.Try recharging again.Service code: 1400.' the patient confirmed they were able to clear the error message and noted that their ins was 50% charged, therapy was on, and the wr had a 'good connection' with the ins.The troubleshooting steps that were taken on the call resolved the issue.2021-jul-29 e1 (rep): additional information was received from a manufacturer representative (rep) reporting that the cause of the connection issue was user error with the placement of the recharger; placing the white recharger side on the chest as opposed to facing outwards, as well as using the wrong application.It is unknown if the issue resolved.2021-09-20 (b)(4) (hcp, rep): additional information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported they were having a hard time getting the patient¿s wireless recharger (wr) to charge the implantable neurostimulator (ins) as they couldn't get it connected.The rep spoke with the patient and was able to get them connected with the wr, but it wouldn't stay connected for more than 10 minutes even though they were sitting still.A different recharger was tried and it wasn't any different so they didn't think it was the recharger that was the issue.It was noted the patient had another manufacturer¿s deep brain stimulation (dbs) device on the opposite side of the chest and they were worried it may be interfering.The rep sent the patient adhesive discs which helped keep the connection better for re charging and allowed the ins to reach a full charge, but it took 3-4 hours.The rep was going to visit with the patient at their next visit and possibly get an x-ray to see the ins in the pocket.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12518031
• MDR Text Key: 272874002
• Report Number: 3004209178-2021-14292
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/23/2021
• Date Device Manufactured: 11/10/2020
• 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: 75 YR