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

Model Number	97754
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while recharging the patient (pt) experienced difficulty removing the implanted neurostimulator (ins) recharger (insr) antenna that had been secured with an adhesive disc.The pt stated that the antenna was hard to remove and had to be peeled off slowly, and after removed the pt's skin looked like it had been burned.No additional symptoms were reported.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
(see (b)(4) for allegations of insr beeping and hard reset.).
Event or Problem Description
Additional information received from the patient reported that they applied burn cream to the area of their skin affected by the burn and that the issues was now resolved.The patient noted that the replacement recharger works fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6614572
• Report Number: 2182208-2017-00716
• Device Sequence Number: 10940893
• Product Code: LGW
• UDI-Device Identifier: 00643169585928
• UDI-Public: 00643169585928
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 97754
• Device Catalogue Number: 97754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/12/2017; 06/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/19/2017; 06/27/2017; 07/05/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR