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

Model Number 37714

Device Problems No Device Output (1435); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 08/01/2021

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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The reason for call was to address an issue w/ the ins.Pt noted they just moved into a new apartment, and for the last 2 weeks (month/year valid) they have been experiencing an issue w/ the ins.Pt stated that they were "working pretty hard" to move, and they think they pulled something loose.Pt reported that it "hurts like the devil" and they cannot get the ins to turn on.Pt also reported that the implant site hurts.Pt stated they initially were not sure if the symptoms were related to the ins or if they were having an "appendix attack".Pt stated they believe the issue is related to the ins because they can't get the ins to turn on.Pt inquired if they should go to an er, and noted that they previously saw their managing hcp "last week", but noted that they did not report the issues to the hcp.Reviewed role of patient services, if it is medically appropriate to seek out medical attention at an er, and redirected the pt to follow-up with the managing hcp.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12334687
• MDR Text Key: 267029308
• Report Number: 3004209178-2021-12542
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2021

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: 04/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/17/2021
• Date Device Manufactured: 06/06/2012
• 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: 69 YR