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

Model Number	977A260
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that they were getting an eri message, ps reviewed and pt was redirected to their  health care professional (hcp).Pt noted they were just told a few weeks ago, in an mri for their back, that one of the leads were loose for they were out of position.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
Concomitant medical products: product id 97712 serial# nmb700509h implanted: (b)(6) 2013 product type implantable neurostim ulator product id 977a260 serial# va1nt7t041 implanted: (b)(6) 2018.Other relevant device(s) are: product id: 97712, serial/lot #: nmb700509h, ubd: (b)(6) 2014, udi#: (b)(4); product id: 977a260, serial/lot #: va1nt7t041, ubd: (b)(6) 2022, udi#: (b)(4).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
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13416542
• Report Number: 2649622-2022-02300
• Device Sequence Number: 14669990
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Date Device Manufactured: 02/05/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male