BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3864013 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11291
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 19, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V549292, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). WITHIN THE WEEK THE PATIENT STARTED SEEING 2 BATTERIES LAYING SIDEWAYS ON THE TOP OF THEIR PATIENT PROGRAMMER SCREEN. IT WAS NOTED THAT THE PATIENT DIDN¿T REMEMBER EVER SEEING THE ONE IN THE MIDDLE BEFORE AND WANTED TO KNOW WHAT THAT MEANT. THE BATTERY IN THE MIDDLE HAD LESS THAN A QUARTER FULL SHOWING. IT WAS REPORTED THAT THE PATIENT THOUGHT IT LASTED 5 YEARS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEEDED THEIR INTERNAL BATTERY REPLACED AND THE FIRST APPOINTMENT AVAILABLE WAS ON (B)(6) 2014. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS EXCELLENT BUT WAS EXTREMELY BUSY AND THE PATIENT WANTED A REFERRAL TO ANOTHER HCP IN THEIR AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339144 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention