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

Model Number 3058

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Deliver Energy (1211); Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Constipation (3274)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that since ¿probably the week after they got the device, july 10th or 11th, the ¿machine does not seem to be working;¿ the patient knows the device is not working because they are constipated.It was also noted that they were implanted because when they had the urge to urinate they couldn¿t get to the bathroom soon enough and they wet themselves, and that is what is happening now.Troubleshooting found that stimulation was off.The therapy was turned back on, and they were on program 2 at 5.8.It was noted that when they first got the device they were on program 3.They were assisted with changing to program 3 and increasing stim, but they were not able to feel stim.They then changed to program 1 and increased to 6.0 but were not able to feel stim.It was reviewed that it takes time to respond to therapy, and the patient stated that they would try program 1.It was recommended that they follow up with their healthcare provider if their symptoms did not resolve.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 patient.The patient was asked what circumstances led to the device not working, they responded that they were still trying to make it work by altering the controller, but without success.They were asked the circumstances that led to the device being off and they responded that they were trying to get the correct setting.They were asked the circumstances that led to not feeling stimulation when the stimulation was on and they responded they feel the stimulation for a short period, but then it goes off.They reported the steps taken to resolve the reported issues were going to see their doctor who told them to keep trying.They reported their symptoms had not been resolved.

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: 7736535
• MDR Text Key: 115943350
• Report Number: 3004209178-2018-17068
• 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,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: 10/28/2019
• 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: 07/27/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 09/04/2018; 08/08/2018
• Supplement Dates FDA Received: 09/18/2018; 10/04/2018
• Date Device Manufactured: 05/02/2018
• 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: 87 YR
• Patient Weight: 67