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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Malaise (2359); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Adverse event date is estimated; month and year are valid.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event 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 pt stated they are getting mri eligibility cannot be determined (code 0131310) due to abandoned product.Pt reported originally when it was time to replace their bladder stimulator pt saw a different surgeon to replace it and pt reported that surgeon "butchered me" and almost killed them.Pt reported that doctor (dr) "just shut the leads in my spine and sewed me back up".Pt reported they became septic and almost died.Pt stated they went back to their original dr and had a new stimulator put in and pt stated they had to heal.Pt stated then about 8 months later they had a neurosurgeon and a surgeon "dig out the leads" so that pt would be eligible for mri scans.Pt stated they originally had abandoned product when they first had mri mode programmed with this implant.Pt stated they are not good with dates so pt had a difficult time recalling event date.Pt stated they are not good with remembering dates due to a fall.Pt later stated that the dr originally "cut"/"clipped" the leads in september of 2019.Pt stated they went in to have the battery changed and they ended up "just flipping the original leads and leaving them in".Pt reported "she put them in the fascia" and stated they had to go back in to have them dug out.Pt stated that was when they got sick and got septic.Pt stated they were offered another appointment by the dr that did this (pt did not provide name of dr) but pt stated they no longer wished to see this dr and pt went back to dr.Miller.The patient was redirected to th eir healthcare provider to further address the issue.

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.

Manufacturer Narrative

Continuation of d10: product id 3093-28, lot# v880221, implanted: (b)(6) 2012, explanted: (b)(6) 2022, 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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16480881
• MDR Text Key: 310681975
• Report Number: 3004209178-2023-02986
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/20/2024; Not provided
• Supplement Dates FDA Received: 03/20/2024; 04/18/2024
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male