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

Model Number	97725
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation or Postural Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
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 trial patient.It was reported that the patient was in a car accident during their cervical spinal cord stimulator (scs) trial while the wireless external neurostimulator (wens) was on.The stim coverage changed after the car accident; they were not getting stim coverage in her shoulders or neck anymore but were still getting coverage in her arms and hands.The patient was instructed to turn the stim off while driving but the patient stated that she did not want to turn the trial stim off because she didn¿t like the surging feeling when turning it back on.The rep then noted that they discussed turning the stim down before turning it back on to prevent this from happening.The patient also noted that they felt as though both the trial wens and their existing lumbar implantable neurostimulator (ins) were not functioning in the same wave length as both the trial wens and the ins were on during the car accident.Due to the difference in wavelength, the patient reported that this made her wobbly by ambulatory and made it difficult to drive in a straight line.To resolve the issue, the trial system would be removed on (b)(6) 2018 and they turned off the stim at the time.There were no further complications reported or anticipated.
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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7749353
• Report Number: 3007566237-2018-02304
• Device Sequence Number: 1908305
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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 Expiration Date: 09/27/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR