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); Failure to Power Up (1476); Malposition of Device (2616); Battery Problem (2885); Unintended Movement (3026); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Micturition Urgency (1871); Therapeutic Effects, Unexpected (2099); Twitching (2172); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: patient product id: 3889-33, lot# va1n51g, implanted: (b)(6) 2018, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: va1n51g, ubd: 09-jan-2022, (b)(4).Occupation: non-healthcare professional.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.The patient reported that their doctor changed the mode/program at her last appointment, which was a much lower setting, and since then she was not getting quite the same symptom control as it was.The patient mentioned however suddenly, things started getting better/feel better in the last 3-4 days (later stated for about 10 days or more like a week), and she could get to the toilet faster, though she has been mostly inside.The patient also mentioned she had noticed the implanted wire buckles back and forth, and when she¿s sitting, it was not easy to locate the ins.The patient stated the patient programmer was not currently powering on, and she was not feeling stimulation.The patient removed, and reinserted new batteries and the patient programmer powered on.The synced with the patient programmer and it showed stimulation was off and was programmed at 2, on 1.5 volts.The therapy was turned on and was reminded that the therapy needed to be on for it to be effective.After that it was noted that the patient felt stimulation.The patient lowered amplitude from 1.5 to 1.0 then turned ins on.At first, they indicated stimulation was causing muscle contractions and was "coming after her." it was reviewed adjusting stimulation to a comfortable level.The patient adjusted amplitude and eventually settled on 1.3, which patient indicated was comfortable.The patient also noted she might feel it when adjusting then later it was ok.Stimulation was felt in the correct area and the patient stated it was a pulse through the muscles in the left buttock/anal area.The patient noted that she had an upcoming appointment with her doctor, either (b)(6) or possibly that week.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: 7732061
• MDR Text Key: 116263961
• Report Number: 3004209178-2018-16936
• 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: 08/14/2019
• 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: 07/27/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 02/16/2018
• 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: 75 YR