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

Model Number 37612

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

Patient Problems Swelling (2091); No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient had implantable neurostimulator (ins) implanted recently in routine battery replacement procedure.Manufacturer's representative (rep) wanted to know how to use the antenna locate (al) feature, because the patient was getting poor coupling since starting to charge.Patient had no bandages and has got an ok from the doctor to charge.Charging was tested in the operating room and got 6 coupling boxes and now the patient cannot get more than 2 boxes.Technical services reviewed device orientation, possible flip, using al feature possible post-op swelling, etc for the rep.Additional information was received stating the patient was going to get a new recharging system to make sure it wasn't a recharger issue.The patient will see the rep and hcp next week to make sure it was not a swelling issue.Additional information was received stating the patient was still having a hard time charging.The ins was in the patient's abdomen.The caller could feel the left and right corners of the ins but not the bottom.The al showed 58/60.When the patient laid on his back, they got 4 coupling bars but when they sit, they get 0-2 bars.It was suggested that the patient wear something tight to get a closer charge.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the cause of the coupling issue was due to some swelling and lots of stomach tissue while sitting up.To try and resolve the issue the consumer laid down to recharge which allowed them to get four coupling boxes.The consumer was going to continue lying down to charge to see if they could recharge easier and follow-up in one week.No further complications were anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10143613
• MDR Text Key: 194808791
• Report Number: 3004209178-2020-10145
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Date Device Manufactured: 09/26/2019
• 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: 54 YR