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

Model Number	3058
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pocket Erosion (2013); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that, per an operative note the caller had, the patient's lead was cut through during a procedure on (b)(6) 2010 that was meant to reposition the ins because the ins had migrated through the skin.The patient then subsequently had their lead and ins replaced in july 2010 but the cut lead remnant remained.Caller doesn't know the length of the lead fragment.Agent sent mri guidelines to caller so they have the details around lead fragments.Per caller, the system has been fully removed so that only the lead remnant remains.
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 3093-33 (lot: v299378); product type: 0200-lead; implant date (b)(6) 2009; explant date (b)(6) 2010.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: INTERSTIM II
• 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: 22343327
• Report Number: 3004209178-2025-11013
• Device Sequence Number: 20962329
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• 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): 06/27/2025

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: 04/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• 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: 06/10/2025
• Initial Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 11/05/2009
• 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...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female