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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 Battery Problem (2885); Device Contamination with Chemical or Other Material (2944)
Patient Problems Reaction (2414); No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a manufacturing representative (rep) and a healthcare provider (hcp) regarding a patient. It was reported that the patient was not having any problems with the implantable neurostimulator (ins), but it had reached end of service (eos). The patient had a device replacement surgery on (b)(6) 2020, and upon the physician opening the pocket, a white milky substance was present. The hcp mentioned that the patient possibly had a reaction to the ins. The physician sent the liquid and ins to be tested by the lab. The device will not be returned to the manufacturer. No further complications were reported or anticipated.

 
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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 Key10173617
MDR Text Key195729357
Report Number3004209178-2020-10646
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2013
Device MODEL Number37714
Device Catalogue Number37714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/03/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/19/2020 Patient Sequence Number: 1
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