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

Model Number	97745
Medical Device Problem Codes	Intermittent Continuity (1121); Energy Output Problem (1431)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/12/2018
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 about an implantable neurostimulator (ins) implanted for spinal pain.It was reported that the patient had an issue with controller where the amplitude will go up and down on its own.The patient noted that the ins was working until the (b)(6), when they started having major breakthrough pain and could not walk and their ankle gave out.The patient said that she then told a rep about this, she says she put a call in on (b)(6) and then they talked to them on the (b)(6) and they told them that my ankle had given out and my breakthrough pain, so on the (b)(6) they helped me adjust it over the phone.The patient said that it was not known at this time, but the issue of the pain returning could be due to the issue of the stimulation has been turning off on its own and they want me to get the controller exchanged.The patient stated she saw a different rep on (b)(6) in the doctor's office and that was when they realized the stimulation was turning up and down on its own and they remember then on (b)(6) they saw it was at 0.1v so it had been turning up and down on its own.The patient says that she met with the rep on (b)(6), and they were suspecting that the stimulation was moving on its own and when they were changing it was going up on its own and went to approximately 5.Eventually they needed the controller exchanged.They did say that the rep had her take battery pack out to reboot the controller as well but this didn't fix the issue.No medical or therapy problem was associated.No symptoms were reported.No further allegations/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: 8082055
• Report Number: 3004593495-2018-01106
• Device Sequence Number: 268721
• Product Code: LGW
• UDI-Device Identifier: 00613994926005
• UDI-Public: 00613994926005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/17/2018

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: 10/18/2018
• Initial Report FDA Received Date: 11/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR