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	11/01/2018
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 consumer regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient's controller was getting hot during the recharge process but they were still able to charge so they didn't call right away.Now the controller wont charge the ins and removing/reinserting the batteries did not resolve the issue.While trying to charge on the day of the report the recharger got hot and then the controller got hot as well.The patient noted that they got so hot that it almost burned a blister onto them.The controller then indicated that it needed to be charged and was showing the orange battery level and it was not flashing the green light when plugged in to indication that it was charging.The controller battery had depleted extremely fast.The patient could hear something rattling around inside the controller when they shook it and stated that it had fallen off their bed 'a few weeks ago.' then the patient noted that the controller was able to charge and was also showing the red warning battery level for the ins.The controller and recharger were both replaced.No further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received stated that replacement of the recharger and controller resolved the recharging issues and the burning sensation with recharging.No further complications were reported.
Additional Manufacturer Narrative
This is the main component of the system that was not listed on the initial report: product id: 97715, serial# (b)(4), product type: implantable neurostimulator.Product id: 97745, serial# (b)(4), product type: programmer, patient.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): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 8111158
• Report Number: 3004593495-2018-01131
• Device Sequence Number: 16577561
• Product Code: LGW
• UDI-Device Identifier: 00613994925985
• UDI-Public: 00613994925985
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 03/22/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/12/2019; 02/25/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/12/2019; 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 79