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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 978b128, lot# va2b1ud, implanted: (b)(6) 2021, product type lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 15-jul-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, friend/family member) regarding a patient who was impla nted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor therapy.The caller called in asking for mri eligibility.Patient services reviewed how to put the device in mri mode and how to activate mri mode.The caller said the screen that said the 'eligibility cannot be determined'.Patient services recommended that the caller follow up with their healthcare professional (hcp).The caller requested the rep call them.When on the mri screen caller say the model number of 3058 and the lead model number of 978a1.The caller misplaced the id card and didn't give serial number from mri screen when asked.The caller requested the rep call them.Patient services emailed the rep.  on (b)(6) 2021, the rep called in reporting that mri eligibility couldn't be determined even though patient has a 978b128 lead with a 3058.The caller conferenced on patient's wife and it was determined that due to lead tip placement full body eligilbity could not be determined.Technical services reviewed that mri eligibility was based on how the patient was programmed.Technical services recommended to have patient meet with rep in person to look at configurations to determine lead tip placement is correct.The caller noted that a different hcp had removed old lead and left ins.Reason for explant was unknown.Current managing hcp implanted a new system.There were no patient complications reported as a result of this event.  2021-feb-16 (b)(4): no new information.[see 704124285 for other hcp removing wire <(>&<)> 704229343 for stim turning down on it's own.].

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11466460
• MDR Text Key: 245937878
• Report Number: 3004209178-2021-04161
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/11/2021
• Date Device Manufactured: 11/17/2020
• 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
• Patient Age: 59 YR