BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3344566 · Received September 12, 2013

    Report

    Report Number
    3004209178-2013-16098
    Event Type
    Injury
    Date Received
    September 12, 2013
    Report Date
    August 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V192312, IMPLANTED:(B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD DIED AND SHE WAS HAVING IT REPLACED. THE PATIENT KNEW THE INS HAD DIED BECAUSE IT DIDN¿T RESPOND TO TELEMETRY FROM THE PATIENT PROGRAMMER. THE PATIENT HAD BEEN INFORMED BY THE HEALTHCARE PROVIDER THAT THE INS WOULD NEED REPLACING EVERY 5 TO 10 YEARS AND IT HAD ONLY BEEN 4.5 YEARS. THE PATIENT DIDN¿T FEEL LIKE THE INS ¿WAS WORKING ALL THE TIME¿ UNTIL IT DIED. THEN, SHE KNEW IT HAD BEEN WORKING. TWO WEEKENDS PRIOR TO THE REPORT WAS ¿HORRIFIC¿ BECAUSE THE PATIENT¿S SYMPTOMS WERE ¿VERY DRAMATIC.¿ THE PATIENT HAD REPORTEDLY STARTED TO NOTICE A CHANGE IN THERAPY DUE TO THE DEPLETED INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457752 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention