BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2664683 · Received July 23, 2012

    Report

    Report Number
    3004209178-2012-05944
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Report Date
    June 25, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V251861, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS HAD A LOSS OF THERAPEUTIC EFFECT SINCE (B)(6) 2012. THE PATIENT SAW HER PHYSICIAN AND PER X-RAY, HER LEADS WERE OKAY. THE PATIENT USED TO BE ABLE TO FEEL THE WIRE AND WHEN SHE WENT THROUGH SECURITY SHE WOULD GET ZAPPED, BUT THAT WASN'T HAPPENING ANYMORE. THE PATIENT WAS NOT AWARE OF ANY ACCIDENT OR INCIDENT RELATED TO THIS. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT INDICATED THAT HER PHYSICIAN TOLD HER THE BATTERY SHOULD LAST 6-8 YEARS. SHE WAS DIRECTED TO CONTACT HER PHYSICIAN. THE PATIENT OUTCOME WAS INDETERMINATE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1