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

Model Number	97745
Medical Device Problem Codes	Computer Software Problem (1112); Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
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 via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that a ¿software problem¿ message was seen on the controller.The patient indicated the message occurred when they used the controller to attempt to turn stimulation on.The rep said this has happened 3 times.The rep reported the patient sees the screen and it shuts down for a while, so they can¿t use their stimulation.Then, they try to use it a couple days later and it turns back on.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 from patient was received.Patient stated controller was not charging and there was no power on the controller, the controller has showed software problem.Rep had patient reset the controller by removing the battery and re-inserted the battery, now the controller would not charge at all.Patient stated she reset controller 50 times and patient had a lot of problems with the controller.A replacement controller would be sent to patient.No further complications 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: 7529520
• Report Number: 3004593495-2018-00506
• Device Sequence Number: 1422834
• Product Code: LGW
• UDI-Device Identifier: 00613994926005
• UDI-Public: 00613994926005
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 11/05/2018

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 Model Number: 97745
• Device Catalogue Number: 97745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1