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

Model Number	37754
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Erythema (1840); Burning Sensation (2146)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.Information was reported that the patient has experienced overheating of their recharger.The patient was sleeping and was awoken by heating of the dermis.The skin was red however the redness was gone after she awoke the next morning.The patient was asleep in bed and lying on the charger paddle.The bed covers could have added to trapping the heat at the charger paddle.The patient called the rep thursday evening (b)(6) 2018 regarding the event.An appointment was scheduled with the patient next week to check her battery and charging equipment.The patient was also asked to call patient services to have a loaner shipped and return her device for evaluation or possible repair.No further complications were reported.No additional patient symptoms were reported.Additional information was received.The patient reported that they recently got burned while charging.The patient confirmed that they were burnt from their recharger on (b)(6) 2018.No further complications were reported.
Additional Manufacturer Narrative
Refer to manufacture report 3004209178-2018-06920 for details and additional information pertaining to this reportable event.Any additional information and follow up will be sent there.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Concomitant medical products: product id: 37714, serial# (b)(4), product type: implantable neurostimulator.Product id: 39565-65, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received on 2018-oct-01 reporting that the lead from t8 to the battery in the hip had the coating shattered.The stimulator was turned off until the lead was replaced on (b)(6).No further complications were reported.

• Brand Name: RESTORE SENSOR
• 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: 7399899
• Report Number: 2182208-2018-00355
• Device Sequence Number: 993335
• Product Code: LGW
• UDI-Device Identifier: 00643169119215
• UDI-Public: 00643169119215
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2018

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 Expiration Date: 04/28/2013
• Device Model Number: 37754
• Device Catalogue Number: 37754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 04/04/2018; 10/01/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 04/10/2018; 10/08/2018
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 93