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

Model Number 3058

Device Problem Failure to Deliver Energy (1211)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Prolapse (2475)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient experienced a loss or change in therapy.The patient stated they had the ins for bowel and still experienced accidents the same as prior to implant.They were using the programmer for the first time and was unsure how to use it.The patient wanted to increase it because they felt that the stimulation ¿needs to be stronger¿.The patient then increased the stimulation from 2.8 to 2.9.Additional information was received and it was reported that the device was not helping control the bowels, as the patient was back in the same pattern as before they got the implant.Patient would get up in the morning to go to the bathroom and would generally go 3 times and was through for the rest of the day, but sometimes it happened later.Patient had an accident and stated they had already increased stimulation due to the accident.Patient stated they did not want to increase stimulation to where they could feel it because when they urinated it felt like a ball that went 'down there'.Patient's physician told them it was just something that happened to people when they got older and took 'the ball', which patient confirmed was part of their body inside fell down, and pushed the ball back up.Additional information was received and it was reported that the therapy did not seem to be working for the patient since implant and it was not helping anything.Since a couple of months ago, the patient was not feeling stimulation, and 3 weeks ago, they tried to increase stimulation but could not feel anything at 3.4.On the day of the report, the patient had a lot of bowel movements, which was noted to be not typical for the patient.The patient would try to increase stimulation until they could feel it and if that did not work, they would try to change the program.The patient was redirected to follow up with their healthcare provider (hcp) regarding their symptoms and program change.Additional information was received and it was reported that the nurse offered to reset the stimulator to 2nd phase.The patient felt the needed to see the doctor since they had other problems caused by the implant.The patient was set on 4.2 and was taking diarrhea pills to harden bowels, hoping they would know when there bowels move.Additional information was received and it was reported that the implant caused the patient to have a pelvic organ prolapse.It was noted that they did not have any other problems that could cause it to happen.It was stated that they could let it go until it causes an infection, or they can have surgery.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer.It was reported the patient met with the health care physician (hcp) a couple of weeks ago and the patient was still not getting results.The patient stated they were still having bowels and the ins was not working for their symptom relief.The patient reported they didn¿t know when they were going to make a bowel and drove them ¿crazy¿.There were no further complications reported/anticipated.

• 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: 7269780
• MDR Text Key: 100041502
• Report Number: 3004209178-2018-03277
• 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
• Report Date: 02/22/2018

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: 09/28/2018
• 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: 01/25/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 02/22/2018
• Date Device Manufactured: 03/31/2017
• 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 Outcome(s): Other