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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC, INC. RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37022
Device Problems Unable to Obtain Readings (1516); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 387360, lot#: va22kdg, product type: screening device. Other relevant device(s) are: product id: 387360, serial/lot #: (b)(4), ubd: 18-sep-2023, udi#: (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The healthcare professional (hcp) reported through a manufacturer representative that ¿there was a problem with the lead¿ and that they were ¿unable to measure resistance. ¿ additional information received stated that ¿unable to measure resistance¿ referred to invalid resistance readings. The lead was replaced as a result of the event and the issue was resolved. There were no surgical interventions planned or performed and the patient was alive with no injury at the time of report. No complications were reported or anticipated.

 
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Brand NameRESTORE
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10301390
MDR Text Key199670385
Report Number2182208-2020-01314
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37022
Device Catalogue Number37022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2017
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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