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

Model Number 977A260

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

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

On 2018-03-05 information was received from a manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that a lead was left inside the patient's body and inactivated.Per the representative, the lead was not taken out.It was left inside the patient's body and not attached to the neurostimulator.It was reported that it was not capped and not possible for future use because it was out of the epidural space.On 2018-may-08 additional information was received from the rep.It was reported that the lead was left per hcp.He left it behind due to more risk to the patient.No impact to the patient except she will not be able to have a full body mri.It was a lead migration.No further complications were reported/anticipated.

• 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: 7573396
• MDR Text Key: 110346096
• Report Number: 2649622-2018-09391
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Date Device Manufactured: 12/21/2015
• 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