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); Energy Output Problem (1431); Defective Device (2588); Insufficient Information (3190)

Patient Problems Incontinence (1928); Complaint, Ill-Defined (2331)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported that the patient monitor was not working, and they could not make any adjustments with the patient programmer because they were seeing the synchronization screen on the programmer and could not get past that screen.The patient confirmed that the issue probably started about 2-3 weeks prior but stated that they did not know.It was noted that they have already tried changing the batteries on the patient programmer.Troubleshooting was done over the phone and the patient reported that they were successful with syncing the programmer with the implant.Additionally, after the issue with the patient programmer was resolved, the patient indicated not feeling stimulation from the interstim implant.The programmer showed stimulation was on and that the implant was currently at 8.5v.When asked if they were noticing symptom control of 50% or greater several times and the patient stated that the implant was to help with their bladder control.It was further stated that the patient had "more trouble with symptoms" and the implant has "not been working".The patient stated that initially she thought the interstim was working fine, but then stated that she has had a few more accidents.The patient noted that she didn't think that was quite right.It was noted that the patient had the ability to change programs and/or adjust stimulation, but the patient was already at the highest setting (8.5v).Additional information reported that the patient had an up coming appointment with a doctor.No patient symptoms reported, and no further complications were reported.

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: 7747049
• MDR Text Key: 116722366
• Report Number: 3004209178-2018-17353
• 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: 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: 07/14/2018
• 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: 07/31/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 01/17/2017
• 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 Age: 68 YR