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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 Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
Product id: 37791, serial/lot #: unknown. Date inaccurate, only the year is valid. 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 spinal pain. It was reported that after about 30 to 45 minutes of charging the ins, the patient's back received a round burn mark from the recharger. In the past the patient could charge for 2. 5 to 3 hours with no issues. The patient did not charge directly over the skin; they used adhesive discs and a spacer and charged over a t-shirt. This happened a couple of weeks ago as well and the burn mark lasted a little longer than this time. The patient did not realize at first what was happening and thought it was a sun burn and then they realized it was a completely round circle of the exact size of the charging pad. On saturday their back had a round burn mark from recharger antenna again after 45 minutes of charging. The patient noted that the burn mark had since went away because once the patient started feeling the burn they took the recharger off. They confirmed the antenna was not damaged. A replacement device was requested. No further complications reported.
 
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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 Key11737803
MDR Text Key247711247
Report Number3004209178-2021-06826
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2014
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2013
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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