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

Model Number	37022
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), product type: screening device.
Event or Problem Description
A manufacturer representative reported that the day prior to the report the patient had an incontinence episode.After this the patient quickly changed their soiled clothing and pulled tape off of the area where the trial lead was secured to their back.After this they were no longer feeling stimulation in the painful area and they were experiencing belly stimulation.Reprogramming was used to move the stimulation back into the needed area.It was unclear if the trial lead had moved.The patient status was listed as ¿alive ¿ no injury¿ and the issue was considered resolved at the time of the issue.The patient had a history of chronic pain and back surgery.
Event or Problem Description
Additional information was received from the manufacturer representative (rep).It was unknown if there was a lead migration.The rep suspected that was what it might have been as the patient was never able to recapture stimulation in the needed area.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE
• 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: 6138437
• Report Number: 3007566237-2016-04214
• Device Sequence Number: 1075994
• Product Code: LGW
• UDI-Device Identifier: 00643169513013
• UDI-Public: 00643169513013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2016

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: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 12/21/2016; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR