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

Model Number	97755
Medical Device Problem Codes	Overheating of Device (1437); Connection Problem (2900)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Burning Sensation (2146)
Date of Event	08/19/2018
Type of Reportable Event	Malfunction
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 manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.The rep reported that the patient stated that the pad (recharger) was causing her back to feel like it burned and leaves a read mark.The patient stated that whether they are leaning on a couch or just sitting up, she was getting the red mark and burning sensation at ins site.Technical services suggested changing the recharge speed to 3 or 2.The patient reported getting "try again" on her controller.The patient stated that they had also noticed discoloration of the recharger wire, where it goes into the recharger pad itself.It was noted that the controller had been replaced multiple times.No further complications were anticipated/reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the patient who was responding back from a follow up letter sent to them.The patient reported their weight at the time of event was (b)(6) lbs, and indicated that the replacement recharger sent to them resolved the feeling of being burned and they are able to successfully charge.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• 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: 7859707
• Report Number: 3004593495-2018-00849
• Device Sequence Number: 13745960
• Product Code: LGW
• UDI-Device Identifier: 00613994925985
• UDI-Public: 00613994925985
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2020

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: 97755
• Device Catalogue Number: 97755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 09/29/2020
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/11/2018; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR