BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2833825 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10308
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3889-28, LOT# V952319, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THE PATIENT WAS 'NOT TOO PLEASED' WITH THE DEVICE. THE REPORTER STATED THAT IT HELPS SOME, BUT DID NOT LAST. IT WAS REPORTED A WEEK LATER THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE REPORTER STATED THAT THE STIMULATION WAS 'TOO HIGH AND FELT LIKE SHOCKING/JOLTING AND IT HURT.' IT WAS NOTED THAT THE PATIENT ADJUSTED HIS STIMULATION TO PROGRAM 1 AND 1.9 VOLTS, WHICH 'FELT GOOD.' THE REPORTER ALSO STATED THAT WHEN HE SAW HIS HEALTH CARE PROFESSIONAL, 'THEY COULD NOT ADJUST STIMULATION PROPERLY AND IT WAS SHOCKING,' SO THE PATIENT 'HAD TO DO ADJUSTMENT HIMSELF.' IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY AND HAD NOT SOUGHT FURTHER HELP. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1