BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT III SENSOR

    MDR report key: 2093208 · Received April 14, 2011

    Report

    Report Number
    3027765-2011-00015
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K101703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(4) 2011, THE PATIENT HAS NOT RETURNED THE DEVICE TO LIFEWATCH. UPON RECEIPT, PRELIMINARY TESTING SHALL BE PERFORMED AND IT SHALL BE SHIPPED TO THE MANUFACTURER FOR FURTHER EVALUATION. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR. MODEL # COM001. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE WAS SHOCKED BY THE SENSOR ON (B)(6) 2011 (DAY 1 OF USING THE DEVICE). THE PATIENT RECEIVED A SHOCK ON HER RIGHT BREAST WHERE THE WHITE LEAD WAS LOCATED AS WELL AS WHERE THE BLACK AND RED LEADS WERE LOCATED. THE PATIENT REPORTED HER RIGHT ARM WAS TEMPORARILY NUMB AS A RESULT. THE PATIENT REPORTED SHE PUT ON THE DEVICE AT 3:38PM AND FELT THE SHOCK BY 11:00PM THE SAME DAY. THE PHONE BATTERY STARTED TO GO DEAD. SHE TRIED TO CHARGE THE PHONE, BUT IT WOULD NOT HOLD A CHARGE. EVERY TIME THE PHONE SCREEN LIT UP, IT WOULD SHOCK HER FROM THE LEADS. SHE REPORTED HER WHOLE RIGHT ARM FELT WARM, STARTED BURNING AND STINGING, AND SHE COULDN'T FEEL IT. ALL OF THE ELECTRODE SITES SHOCKED HER, BUT THE ONE ATTACHED WITH THE WHITE LEAD WIRE WAS THE WORST. THE SHOCK STARTED GRADUALLY, INCREASED, AND KEPT HURTING. IT WAS INTERMITTENT (6 TIMES). THE PATIENT'S MOTHER CALLED LIFEWATCH AND WAS INSTRUCTED TO REMOVE THE DEVICE. THE PATIENT TEMPORARILY LOST A LITTLE BIT OF FEELING IN HER ARM. AS OF (B)(6) 2011 WHEN THE PATIENT WAS INTERVIEWED, SYMPTOMS HAD RESOLVED. NO PERMANENT INJURY WAS INCURRED. THE PATIENT PRESENTED AT THE EMERGENCY ROOM FOR THE NUMBNESS IN HER ARM. HER STATS WERE CHECKED AND NO EFFECT WAS NOTED. THEY SAID THE SMALL AMOUNT OF VOLTAGE CURRENT SHE RECEIVED SHOULD NOT HAVE DONE ANY PERMANENT DAMAGE. THE ELECTRODE THAT WAS ON HER COLLAR BONE MAY HAVE JOLTED HER AND CAUSED THE NUMBNESS. SHE WAS DISCHARGED THAT SAME NIGHT AND SENT HOME TO REST. SHE WAS NOT ADMITTED NOR WERE ANY MEDICATIONS PRESCRIBED FOR TREATMENT. SHE WAS ADVISED TO FOLLOW-UP WITH HER PHYSICIAN IF IT HAS ANY EFFECT LATER ON, BUT IT HAD NOT HAD ANY EFFECT AS OF (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT III SENSOR DETECTOR AND ALARM, ARRHYTHMIA DSI LIFEWATCH SERVICES, INC. DEV060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other PRILOSEC| PAXIL| BIAXIN| CADIZEM| XANAX