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

Model Number	97754
Medical Device Problem Codes	Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Codes	Erythema (1840); Burn, Thermal (2530)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the recharger (b)(4) found no significant anomalies.The recharger was successfully charged, and was able to ch arge a known good ins without incident.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
A patient with an implantable neurostimulator (ins) reported that her charging antenna became hot when in use.She visited her healthcare provider (hcp) because she was having trouble getting the ins charged, as the antenna burns her back after charging for an hour, and her back becomes red.The patient met with a manufacturer's representative (rep) at the clinic and charged for an hour with the rep's charger, and the antenna became warm but did not get too hot.Patient did not recall seeing the thermometer icon on the recharger.Patient was implanted for non-malignant pain.
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: 6121428
• Report Number: 2182208-2016-02604
• Device Sequence Number: 16196157
• Product Code: LGW
• UDI-Device Identifier: 00643169109469
• UDI-Public: 00643169109469
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: 11/03/2016
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR