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

Model Number	977A275
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
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 manufacturer representative from a health care provider regarding a patient who was implanted with a neurostimulator.It was reported that there was a lead malfunction that occurred intra-operatively.The lead was implanted partially, but when they tried to remove the stylet, it would not come out.They tried to gently remove the stylet for several minutes and ultimately the steering cap popped up.Forceps were used to try to grab the stylet and remove, but could not.The lead was removed from the epidural space, and a new lead was used.The stylet could not be removed from the lead, and the manufacturer representative watched the health care providers try for almost 10 minutes.There were no patient symptoms or complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the lead (b)(4) found the stylet could not be removed from the lead.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6702502
• Report Number: 2649622-2017-07614
• Device Sequence Number: 16357736
• Product Code: LGW
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2017

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: 04/21/2021
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 08/24/2017; 09/29/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 07/25/2017; 08/31/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR