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); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer representative reported that the patient was having the full system replaced due to needing an mri so they were implanting a new mri safe implant and lead.The healthcare professional (hcp) removed the old lead with an angiocath to try to maintain the original lead track.The lead was removed and the new lead inserted into the angiocath and it appeared to be going easy into the epidural space.Then the lead appeared to be going anterior and the hcp removed the stylet multiple times and used all the different stylets in the kit.The hcp indicated it seemed like the stylet was catching on the electrodes on the distal end and the stylet would only advance to within 1-2 inches from the distal end of the lead.Flouro was showing some curving but nothing remarkable.The hcp opened a new lead and didn¿t have issues but had to use the needle to advance the lead instead of the angiocath.No patient symptoms reported.
Additional Manufacturer Narrative
Analysis of the stimulation lead (serial number (b)(4)) found that multiple known good stylets were able to be fully inserted into the lead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow up report will be sent once analysis is complete.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.

• 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: 6793969
• Report Number: 2649622-2017-10118
• Device Sequence Number: 1511647
• Product Code: GZB
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• 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,Followup
• Report Date (Section B): 10/19/2017

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: 06/14/2021
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/17/2017; 09/06/2017; 10/18/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/06/2017; 09/12/2017; 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 51