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

Model Number	977A275
Medical Device Problem Codes	Difficult to Insert (1316); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received via a healthcare professional from a manufacturer representative regarding a trial for pain therapy.While implanting the electrode, the doctor stated that it was hard to pass through and felt it was too narrow.The patient didn't report any issues.There were no factors noted that may have led or contributed to the issue.The doctor couldn't figure out what was wrong with either the cannula or the electrode.The doctor tried to pass it through until he made it.It was also reported that, even though the cannula presented a problem while introducing the electrode, the doctor was able to pass it through.The issue was resolved at the time of the report.No patient complication was associated with the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS 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: 6654320
• Report Number: 2649622-2017-07576
• Device Sequence Number: 16464947
• Product Code: LGW
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2020
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1