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

Model Number 3058

Device Problems Energy Output Problem (1431); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for gastrointestinal /pelvic floor therapy.It was reported the patient was having problems with his stimulator, stated it didn't seem to be working.The patient clarified that he was having issues with diarrhea and not having enough warning before going to the bathroom so he makes a mess/had a return of symptoms since around (b)(6) 2018.The patient also reported an issue with their programmer, he used to be able to use his programmer to adjust his stimulator but he hasn't been able to now.Troubleshooting included the patient syncing the programmer with the ins which showed the device was on program 2 at 1.0 and when trying to increase saw the upper threshold limit screen.The patient was advised to contact their hcp regarding symptoms and programming.Additional information was received from the patient and manufacturer's representative on (b)(6) 2018: the patient called back reporting the same thing that was previously documented and states he wants to know more about changing programs and specifically wants to meet with a local representative.Patient services offered to assist over the phone with providing education on the programmer, but the patient declined because he did not have the programmer with him.The rep planned to contact the patient by friday, (b)(6) 2018.No further complications were reported or are anticipated.

Manufacturer Narrative

Due to imrdf harmonization, some previously submitted device, method, result, and conclusion codes related to this event were updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient via the manufacturer's representative: the patient just needed assistance on how to change his program, and he is all set.No further complications were reported or are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via the manufacturer's representative: the cause of the upper limit screen was not determined, and the issue was just a simple explanation on how the patient could change programs.No further complications were reported or are 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: 7665144
• MDR Text Key: 113283451
• Report Number: 3004209178-2018-15116
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 06/14/2018
• 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: 06/22/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/09/2018; 07/17/2018; 08/08/2018
• Supplement Dates FDA Received: 07/17/2018; 07/18/2018; 10/05/2018
• Date Device Manufactured: 12/20/2016
• 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: 75 YR