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

Model Number	3058
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	04/03/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that  the ins had to be explanted because their body was rejecting it.The patient thinks this occurred in (b)(6) 2011.The patient stated that the explant procedure took a long time, so the hcp decided to leave a little piece of the lead in the scar tissue.The patient mentioned that they had fluoroscopy which detected a metallic foreign body, which was then identified as the lead fragment.The patient's reason for calling was to find out if they could get an mri of the sacral and lumbar area.The patient mentioned that they were having back pain and their hcp was trying to determine the root cause.The agent reviewed mri compatibility.The agent reviewed that an hcp will need to fill out an mri eligibility form for lead fragments.The agent emailed physician listings to the patient.Agent also emailed prs to update the device record.
Additional Manufacturer Narrative
Continuation of d10: product id 3093-28, lot# v386611, implanted: (b)(6) 2010, explanted: (b)(6) 2012, product type lead.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
Additional information was received from the hcp via medical records.The hcp reported that the patient initially presented with urinay retention and was implanted on (b)(6) 2010.They reported that the benefit of the stimulation diminished and the stimulator had begun to bother the patient's daily activities so the patient wanted it removed on (b)(6) 2012.It was reported that the device was removed but when the permanent lead was pulled, it would not deliver, so they reopened the original lead insertion site.They grasped the lead with the right angle clam and extracted it from the incision however with direct tension only a portion of the lead delivered.It appeared that the tines and the leads remained in the patient.They discussed how to proceed with the surgery at that point and decided to close and discuss wheter or not to perform a more extensive extraction with the patient.They reported that the patient received preoperative antibiotics per protocol.
Additional Manufacturer Narrative
Continuation of d10: product id 3093-28 lot# v386611.Implanted: (b)(6) 2010.Explanted: (b)(6) 2012.Product type lead 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
Additional information was received from the hcp via medical records.The hcp reported that the patient initially presented with urinay retention and was implanted on (b)(6) 2010.They reported that the benefit of the stimulation diminished and the stimulator had begun to bother the patient's daily activities so the patient wanted it removed on (b)(6) 2012.It was reported that the device was removed but when the permanent lead was pulled, it would not deliver, so they reopened the original lead insertion site.They grasped the lead with the right angle clam and extracted it from the incision however with direct tension only a portion of the lead delivered.It appeared that the tines and the leads remained in the patient.They discussed how to proceed with the surgery at that point and decided to close and discuss whether or not to perform a more extensive extraction with the patient.They reported that the patient received preoperative antibiotics per protocol.

• Brand Name: INTERSTIM II
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 23077230
• Report Number: 3004209178-2025-15781
• Device Sequence Number: 20030039
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: (01)00613994287724(17)111014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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: 10/14/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 09/16/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/03/2025; 10/10/2025
• Date Device Manufactured: 04/27/2010
• 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....".; "SEE H11....".
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female