MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA

Model Number 37612

Device Problems Unstable (1667); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 03/07/2021

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 is having issues maintaining a consistent coupling interval to charge her implantable neurostimulator (ins) in a reasonable amount of time.The ins pocket is deep and the breast tissue puts it at an angle making it challenging to charge.They attempted multiple locations around the device, tried adhesive discs, and antenna locator function with limited success.They would like to try the new wireless recharger (wr) in hopes that the wr will provide a better connection and be more comfortable for her, easing this task.Additional information was received from a manufacturer representative (rep) reporting they met and educated the patient today about the wireless recharger (wr).The left chest device worked out well, but the right chest device still had challenges in connecting consistently.It is not the recharging equipment but because of where it is implanted.The patient is going to try some different positions next sunday and will see.They charge once per week.

• Brand Name: ACTIVA
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11529959
• MDR Text Key: 245213492
• Report Number: 3004209178-2021-04603
• Device Sequence Number: 1
• Product Code: MRU
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2021

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: 12/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2021
• Initial Date FDA Received: 03/19/2021
• Date Device Manufactured: 01/24/2011
• 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: 33 YR