MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Improper or Incorrect Procedure or Method (2017); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that the patient's recharger was not working.They received a reposition antenna screen over the weekend.The patient had not charged the ins for about 2 months.They were told not to use their device, as they were getting blood injections and the injections made their legs swell up.The patient noted that they had spoken with a rep about the issue and the rep reviewed that the ins may need to be jumpstarted.The patient was redirected to meet with a rep or healthcare provider (hcp) for further troubleshooting.No symptoms were reported.Additional information was received from the manufacturer representative (rep).It was reported the battery was overdischarged.The patient was told not to use the stimulator during her course of knee injections.She was not charging her battery during that time either.Last charging session was in february.Manual battery reset was performed and successful.There was power on reset (por).The issue was resolved.It was also reported that the patient was charging about 12 hours per day and she was wanting to upgrade her ins.No patient symptoms were reported.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 10353288
• MDR Text Key: 201417774
• Report Number: 3004209178-2020-13258
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Date Device Manufactured: 08/29/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR