BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5467284 · Received February 29, 2016

    Report

    Report Number
    6000153-2016-00660
    Event Type
    Injury
    Date Received
    February 29, 2016
    Date of Event
    November 3, 2015
    Report Date
    April 14, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (L/N V252847) SHOWED THAT THE LEAD BODY/ CONDUCTOR WAS CRUSHED; THERE WAS NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTH CARE PROFESSIONAL (HCP) VIA THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THAT FOLLOWING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT ON (B)(6) 2016, THE DEVICE THERAPY WAS NO LONGER EFFECTIVE AND CAUSED THE PATIENT SOME DISCOMFORT. A LEAD REVISION PROCEDURE WAS DONE TO IMPROVE EFFICACY. THE IMPEDANCE TEST DEMONSTRATED 4 COMBINATIONS OUTSIDE OF NORMAL PARAMETERS. THE IMPEDANCE TEST AFTER THE IMPLANTATION OF THE NEW LEAD WAS BAD. THE 4 MONTH OLD IPG NEEDED TO BE REPLACED. IT WAS UNKNOWN IF THE ISSUE RESOLVED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THE PROSPECTIVE PATIENT REPORTED THAT THE LEAD HAD MOVED. ALL PROGRAMS WERE TRIED AND REPROGRAMMING WAS PERFORMED. NO X-RAYS WERE DONE BUT THE DOCTOR KNEW THE LEAD WAS IN A DIFFERENT PLACE. THE REVISION HAD NOT OCCURRED BUT WAS SCHEDULED. THE DATE WAS UNKNOWN. THERE HAD BEEN NO SYMPTOM RELIEF AND THE LEAD FELT LIKE IT HAD MOVED. IT WAS NOTED THAT IT MAY NOT HAVE BEEN PLACED RIGHT IN SURGERY. THIS EVENT HAD BEEN REPORTED AS SUDDEN. RELEVANT MEDICAL HISTORY INCLUDED URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT ACTIONS WERE TAKEN TO ADDRESS THE EVENT AND IF IT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125306 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3889-28 V252847

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention