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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
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.

 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, 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 Key12334687
MDR Text Key267029308
Report Number3004209178-2021-12542
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2013
Device MODEL Number37714
Device Catalogue Number37714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/06/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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