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

Model Number 977A260

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of pli# 10 product id#: 977a260 found stim lead/body/stylet coil/perforated by stylet.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that the hcp could not re-insert the guide wire during implant.Tried to re-insert however not successful.Lead to be returned.Issue resolved.No symptoms reported.No further complications were reported/anticipated.

Manufacturer Narrative

An update/ correction was made to reflect most accurate information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9617302
• MDR Text Key: 178122540
• Report Number: 2649622-2020-01764
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00763000006501
• UDI-Public: 00763000006501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR