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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Device Difficult to Program or Calibrate (1496); Battery Problem (2885); Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The caller reported that about 3-4 days following implant the patient had a little bit of a leak, they noticed they were not getting therapy relief, so they wanted to increase stimulation.Caller stated they thought the device was already set up, but when they checked therapy status to increase stimulation due to this, caller noted stimulation was at 0.0.Caller stated the rep informed them on the date of implant to set up the device, caller stated they were not sure if it was set up correctly because it was at 0.0 when they checked the status.Caller stated maybe 3 days prior they had increased stimulation to 0.2 volts and they stated at the time of the report nothing seemed to be working.They stated they were advised to increase stimulation until the patient felt the tingle of stimulation.They reported the patient had not felt stimulation and increased on program 1 from 0.2 to 1.3 volts the day of report.They were having a lot of leakage at the time of the report.It was noted they were not feeling stimulation.Caller increased stimulation to 1.9 volts on the call and they stated they were still not feeling stimulation.It was noted the patient was sitting, so they stood up and still did not feel stimulation.They were redirected to their healthcare provider to further discuss programming.They were also advised to monitor symptoms at this setting.

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

Additional information was received from the patient's representative.They reported that the patient was pretty much unable to speak for themselves anymore and even though they did the "hippa" thing, the patient's old health care provider (hcp) office wouldn't talk to them about the patient's medical issues.The caller stated they recently got a message that said "low battery.Internal device battery is low".Patient services reviewed the information on what this message meant with the caller and sent the caller physician listings at the caller's request.Caller stated the hcp had told them the device would last for 7 years and it had not lasted 7 years considering when the implant took place.It lasted not as long as the hcp said it would.Caller also confirmed they would have the implant at high settings (5.Something v or 4.Something v.) patient services reviewed battery longevity considerations with the caller and the caller stated while the therapy helped the bladder a little and even the bowel a little (though it was not intended for the bowel) the therapy hadn't really helped the patient that much.The caller reiterated that they had spoken with a medtronic representative named (b)(4) that they texted back and forth with but the caller stated the hcp told them they really didn't have the medical knowledge to help the patient find the relief they were looking for.Caller stated the doctor could never answer any of their questions and they never understood what they were supposed to do they would be switching programs and adjusting the stimulation not quite understanding what needed to be done.Patient services reviewed the role of the rep with the caller because they had asked for the number of a new rep but also device description/function with the caller and programming and stimulation considerations with the caller and reviewed options to discuss with a new hcp when they met with the hcp to discuss the low battery message.Caller stated patient didn't necessarily want to get another system implanted because it might not be very beneficial but noted that they would follow up with an hcp about the low battery message and possibly discuss getting the battery replaced.Caller also discussed that the patient wanted to be cremated when the time came (which they said would be sooner rather than later) so patient services also reviewed cremation considerations with the caller.Reopened case to send caller health care provider (hcp) listings.Documented reported eve nt.No further action was taken by patient services.

• 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: 11026740
• MDR Text Key: 222030187
• Report Number: 3004209178-2020-22076
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: 04/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 10/15/2020
• 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: 81 YR
• Patient Sex: Female