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

Model Number 977A275

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

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

Event Date 08/08/2017

Event Type  malfunction  

Event 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.

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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 6793969
• MDR Text Key: 82679232
• Report Number: 2649622-2017-10118
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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: 82 YR
• Patient Weight: 51