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

Model Number 3058

Device Problems Difficult to Remove (1528); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2022

Event Type  malfunction  

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 they were wanting to know about what they needed to do for an mri.Patient services walked the patient through connecting to their settings and activating and deactivating mri mode.The mri mode said 'mr conditional full body scan eligible" however when talking with the patient, the patient reported that when their current system was implanted, the surgeon was able to replace their ins battery with no issue however "something got screwed up" and the surgeon could not retrieve "something" so they closed the patient up with the "something" from their previous system still inside of them.The patient stated the procedure was supposed to have been 25 minutes but it ended up being an hour because of the surgeons inability to remove a piece.Patient services reviewed with the patient that if they had an abandoned component inside of them still, then their mri mode would need reflect that and it currently didn't.The patient was going to follow up with their hcp about their mri mode programming and patient services sent an email to the field regarding the situation.The patient's relevant medical history included the patient stated they needed an mri of their arm because their "arm exploded" after a flu shot.The patient further explained a tendon or muscle got damaged from the shot and the arm was now "shot," and they needed an mri of the arm to know how to treat it.The patient stated they'd already done a ct scan but the ct scan didn't give any answers so an mri was needed.Patient also confirmed that their previous system replacements had been done because of normal battery depletion.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va218nu serial# implanted: (b)(6) 2019 explanted: (b)(6) 2022 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(6), ubd: 23-jul-2023, udi#: (b)(4) 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.

• 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: 18275646
• MDR Text Key: 329845418
• Report Number: 3004209178-2023-25274
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2023
• Date Device Manufactured: 07/23/2019
• 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 H10...."
• Patient Age: 86 YR
• Patient Sex: Female