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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 PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Break (1069); Connection Problem (2900); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 3708220 serial#: (b)(4), implanted: (b)(6) 2011, product type: extension. Other relevant device(s) are: product id: 3708220, serial/lot #: (b)(4), ubd: 17-aug-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation. It was reported that during removal of ins the hcp bent off the tip of the extension and was unable to place the extension into the new battery. Hcp proceeded however was unable to fully seat the extension into the battery and connected the extension partially into the battery. Upon checking connectivity, there were 4 of the electrodes functional along with the lead. The rep was able to achieve satisfactory stimulation pattern for the patient with the active electrodes. The impedances were evaluated during and after procedure. Active electrodes were utilized to program a satisfactory stimulation pattern to cover the patient's pain area. Issue resolved at this time.

 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, 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 Key10344013
MDR Text Key201003513
Report Number3004209178-2020-13128
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2012
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 Received07/28/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/11/2011
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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