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

Model Number	977C165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Chest Pain (1776); Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 97716, serial#: (b)(4), implanted: (b)(6) 2021, product type: implantable neurostimulator.Other relevant device(s) are: product id: 97716, serial/lot #: (b)(4), ubd: 14-aug-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from an health care professional (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that  the pt developed chest pain a couple of days after lead implant and went to the er.She received a medtronic pacemaker and was hospitalized.She still could not use her left leg after nearly 2 weeks of working with physical therapy, so surgeon opted to remove paddle.He said there was a lot of fibrous tissue around the paddle.Pt's leg mobility improved slightly after explant.The paddle lead was implanted on (b)(6) 2021, and explanted on (b)(6) 2021.Surgeon reports patient could not move legs in recovery but was able to move the right leg.Paddle lead explant (b)(6) 2021 ipg remains implanted.

• Brand Name: SPECIFY 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: 13011711
• Report Number: 2649622-2021-24892
• Device Sequence Number: 14644812
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 08/16/2023
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/15/2021
• Date Device Manufactured: 08/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female