MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	3023
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that the ins, extension and partial lead were removed on (b)(6) 2020.Hcp inquiring if pt is eligible for mri.Hcp states, via imaging, they see 4 electrodes, one radiopaque marker and then a braided portion of the lead without a radiopaque marker, perhaps in two separate pieces.Hcp then read from the operative note stating, "gentle rocked the lead to lift it from the fascia however during this process the lead fractured and only the first 2 or 4 tines were removed, the remaining tines were still in s3.Any efforts to extract what remains is futile".
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name interstim; product id: 3889-28, (lot: v295482); product type: 0200-lead; implant date: (b)(6) 2009.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21928834
• Report Number: 3004209178-2025-07400
• Device Sequence Number: 9073289
• Product Code: EZW
• UDI-Device Identifier: 00613994287731
• UDI-Public: 00613994287731
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: 11/14/2010
• Device Model Number: 3023
• Device Catalogue Number: 3023
• 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: 04/25/2025
• Initial Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 05/22/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 77 YR
• Patient Sex: Female