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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Therapeutic Effects, Unexpected (2099)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

Date of the event was estimated.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient was implanted the day prior to the report, and the device was no longer working.The patient stated that the monitor would not cooperate and they had to have it rebooted at the health care professional's office.The patient confirmed that when she got home from implant surgery the patient programmer kept showing the call the doctor icon with power on reset (por) message.The patient noted that she was told it had to be rebooted and that was when the manufacturing representative came in to reboot the device.The patient also mentioned that she had a regular bowel movement this morning and since then she had 3 diarrheas and barely made it to the bathroom.The patient wanted to know if it was something that had to do with her monitor of if she had gotten a bug.The patient confirmed that she was feeling the stimulation but this afternoon she hadn't felt anything.Troubleshooting attempts were made and the patient programmer showed stimulation was on at 3.1v.The patient increased stimulation and confirmed she felt stimulation.The patient was redirected to her health care professional.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the cause of the device not working and the por was not determined, and that the device not working and diarrhea had not been resolved yet.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7664726
• MDR Text Key: 113265825
• Report Number: 3004209178-2018-15096
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 11/14/2019
• 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: 06/30/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 08/08/2018
• Supplement Dates FDA Received: 07/20/2018; 10/04/2018
• Date Device Manufactured: 05/16/2018
• 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: 76 YR
• Patient Weight: 66