MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	978B128
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Impedance Problem (2950)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency) it was reported that patient fell in january and then couldn't increase stim past 0.7 and their symptoms got worse from the loss of therapy.Rep interrogated device and found the same issues, impedance at electrodes 1 and 3.Imaging showed lead was also dislodged so hcp replaced with new lead.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 19143720
• Report Number: 2649622-2024-10894
• Device Sequence Number: 18122898
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: 00763000203726
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/19/2024

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: 01/20/2024
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2LCQL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Date Device Manufactured: 05/05/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female