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

Model Number 977A260

Device Problems Break (1069); Positioning Problem (3009); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.Information was reported that the rep stated they did a complete system replacement today.The lead and ins were replaced.The rep said "something was wrong with the lead".The rep said she does not know what was wrong because a different rep initially saw the patient.During the lead revision today the introducer "frayed" and the doctor was unable to puncture the dura.The doctor used a needle instead.Additional information was reported that the replacement was due to a change in the patient's coverage making the lead suspect and an updated battery.No further information was reported.

• 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: 9527848
• MDR Text Key: 177141543
• Report Number: 2649622-2019-24491
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Date Device Manufactured: 09/03/2019
• 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 Outcome(s): Required Intervention