MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	977D260
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	11/17/2017
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 regarding a patient with an external neurostimulator (ens), and it was reported that during implant the lead was initially placed at the t8/9 level, but when the doctor pulled out the needle the lead slipped to the t11/12 level, and though the doctor tried to advance the lead, she was not able to get original lead placement.The patient had a good trial with significant pain relief.It was also reported that the trial stimulator had come detached from the patient during the trial, and the rep believed that this caused further migration leading to a loss of stim, however the rep was still able to get the patient to experience stim after this with reprogramming, before the lead was removed at the end of the trial.There were no reported complications and no further complications were expected.Patient was implanted for trial stimulation.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7119175
• Report Number: 2649622-2017-15607
• Device Sequence Number: 1298206
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 09/18/2021
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1