BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6269144 · Received January 22, 2017

    Report

    Report Number
    3004209178-2017-01429
    Event Type
    Injury
    Date Received
    January 22, 2017
    Date of Event
    August 17, 2007
    Report Date
    January 22, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V043575, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT REPORTED SHE NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED SINCE SHE WAS IMPLANTED THERAPY DID NOT HELP HER. THE PATIENT NOTED SHE HAD 3 DIFFERENT SURGERIES WHERE THE HEALTHCARE PROFESSIONAL (HCP) TRIED MOVING IT TO WHERE IT WOULD WORK. THE PATIENT STATED THE LAST REVISION SURGERY SEEMED TO WORK A LITTLE BIT. THE PATIENT STATED THEY MET WITH THE MANUFACTURER REPRESENTATIVE (REP) SEVERAL TIMES, BUT EVEN THE REP HAD A HARD TIME GETTING IT TO WORK. THE PATIENT NOTED AFTER ALL THE TRIPS AND THERAPY NOT WORKING THE PATIENT GAVE UP. THE PATIENT STATED SHE DID NOT WANT TO GO THROUGH A SURGERY TO HAVE IT TAKEN OUT. THE PATIENT NOTED ALL 3 REVISIONS WERE IN 2007. THE PATIENT IS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52123 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention