MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97755
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximation only the year is valid.The device was returned; however, analysis was not performed because the cable insulation was torn so the device was scrapped.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient regarding their implantable neurostimulator (ins) for non-malignant pain.Information was reported that a couple months ago, the patient's controller battery started depleting more quickly to where the cont roller would deplete from 100% charge to 40% charged in 15 minutes.The patient said this morning he noticed that the controller itself was getting hot and so was the recharge antenna, so hot that it burnt his rear end.The patient is being sent new external devices.No further complications were reported.No additional patient symptoms were reported.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 9558764
• Report Number: 3004593495-2020-00009
• Device Sequence Number: 11348125
• Product Code: LGW
• UDI-Device Identifier: 00613994925985
• UDI-Public: 00613994925985
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 12/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR