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

Model Number	978B128
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction.It was reported that hcp was doing a full implant on the pt.The first lead was initially implanted when the hcp was deploying the tines, the lead shifted towards s2.At this point the introducer was fully removed.Hcp tried to adjust the lead after deployed with no improvement in responses.She tried to reinsert the lead introducer sheath over the lead to manipulate the lead back in proper position.In the attempt to do this, the introducer sheath bent and could not advance into fully into the foramen.Hcp was concerned the lead was possibly damaged because of this and completely removed the lead introducer sheath and the lead.Due to possible risk of damaged lead, requested to open a new lead kit and start over.The new lead kit used was the a new lead.The new lead was placed without incident.No patient harm or damage done and patient responses appropriate.Removed lead and lead introducer will be sent back tomorrow 4/25/24.
Additional Manufacturer Narrative
Continuation of d10: product id 3550-18 lot# serial# unknown implanted: explanted: product type accessory product id 978b128 lot# (b)(6) serial# (b)(6) implanted: (b)(6) 2024 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3550-18, serial/lot #: unknown, ubd: , udi#: h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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.
Additional Manufacturer Narrative
H3: analysis of the lead (lot#: va2uxec) revealed that the returned device passed all testing in the laboratory and no anomalies were identified.Analysis of the kit revealed that the lead introducer sheath was damaged.Continuation of d10: product id 3550-18 lot# serial# unknown implanted: explanted: product type accessory 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.

• 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: 19273475
• Report Number: 2649622-2024-12738
• Device Sequence Number: 12528174
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: 00763000203726
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2025
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2UXEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 98 KG