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

Model Number 37714

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).The patient reported that since the ins was put in they had lost a lot of weight.The patient stated that their ¿ins was kind of just hanging there¿.They stated that they noticed it over three years ago.At the time their healthcare provider (hcp) had left their practice.They reported that since (b)(6) 2020 they had been getting kind of like an electric shock where the ins was in their left side of their butt.They stated that they saw their surgeon today who thinks that their battery might be leaking and they wanted a rep to come out and check their device.Patient services asked what the surgeon meant by ¿leaking¿.The patient explained because they were getting the shocking sensation.The patient was redirected to follow-up with the hcp.Additional information was received from an hcp the next day, reporting that the patient wanted to have their scs (spinal cord stimulator) system checked because they were having some type of discomfort with the system.The hcp indicated that they didn¿t have any further details on the nature or timing of the discomfort.The event date was asked but was unknown.No further complications were reported/anticipated.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 10195556
• MDR Text Key: 196438573
• Report Number: 3004209178-2020-11054
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 06/25/2020
• Date Device Manufactured: 11/05/2014
• 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