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

Model Number 97810

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Charging Problem (2892); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Irritability (2421); Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

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.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they had trouble with their interstim micro off and on.Patient stated they th ought it was due to the positioning of the implant that made it hard to reach/hard to work with.Patient stated a couple years ago "around halloween" they worked with a medtronic representative and with a "male student" who helped the patient get setup to charge.Patient stated they were able to charge the ins after that, however then the handset "stopped working" "about a year ago", that there appeared to be "nothing on it" (but they weren't sure because they hadn't turned it on in a long time) and they weren't able to get to their settings or charge their ins plus the stimulation was really starting to bother them going down their leg, it was aggravating, so they stopped using it and went to medication instead.Patient stated the medication was doing a pretty good job and they really didn't have a need for the therapy any longer.Patient's initial reason for call was because they needed mris done of their cervical spine and to possibly check their nerve and why they were having tingling in their arm so they had called to inquire about mri compatibility.Patient services had the patient plug in their galaxy j3 handset and the patient was able to see a lightning bolt and the outline of the battery but they were unable to turn the handset on at the time of the call.Patient was going to continue charging the handset.The patient had also plugged their recharger into the dock and was going to let that charge.Patient stated they may call back to troubleshoot the issue with the phone but in reality, they just wanted the device out so they could get mris.Patient stated their managing health care provider (hcp) had retired and they were now just seeing a physician's assistant (pa) so patient services sent the patient physician listings at the patient's request.Patient stated they were rarely able to use the recharger belt and they had to hold the recharger with their arm which was tingling and the arm tingling was related to why they needed an mri of their cervical spine to figure out what was going on.Patient services provided patient with the technical services team for their doctors if they needed to remove the system asap and the patient was in the meantime going to locate a physician to assist in removing the implanted system.Patient services sent the patient physician listings and reviewed with the patient that if they decided they wanted to troubleshoot the handset and charge the ins to call patient services back.Patient services wanted to note that the patient was difficult to follow and so patient services did their best to collect the reported information and assist the patient with their reason for call.Documented reported event.No further action was taken by patient services.Caller called with components charged.Caller was unable to find ins with communicator.Switched to recharger and the caller was able to see 10% by the end of the call.Reviewed to try to get up to 40% and then call us back for help with mri mode.The caller noted that it may take some time to get it charged enough, due to not being able to hold the recharger long due to arm problems.Reviewed to try the belt or a different body position.The caller noted that their ins is at an odd angle in the body. caller called back, caller was able to navigate to mri mode and activate it, seeing full body eligible.Reviewed to keep components charged and ins charged to at least 30% prior to mri appt.

• Brand Name: INTERSTIM
• 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: 19150108
• MDR Text Key: 341302666
• Report Number: 3004209178-2024-09462
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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: Other
• Type of Report: Initial
• Report Date: 04/21/2024

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: 11/14/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/21/2024
• Date Device Manufactured: 05/21/2020
• 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: 64 YR
• Patient Sex: Female