BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1694309 · Received May 19, 2010

    Report

    Report Number
    2017865-2010-02308
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    April 18, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND INSULATION ABRASION ON THE IS-1 LEG AT 5.5CM FROM THE CONNECTOR PIN. THE INSULATION ABRASION FOUND IS CHARACTERISTIC OF LEAD FRICTION TO THE ICD CAN. AN INSIDE OUT ABRASION WAS NOTED AT 8CM FROM THE DISTAL TIP. THE EFTE CABLES WERE EXPOSED BUT NOT ABRADED AND THE DISTAL COIL WAS EXPOSED IN THIS AREA.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED CUSTOMER RECEIVED A READING OF 120 MG/DL FROM THEIR FREESTYLE LITE METER WHICH WAS HIGHER WHEN COMPARED TO AN UNSPECIFIED READING FROM ANOTHER ADC METER (THE SERIAL NUMBER IS UNKNOWN). CUSTOMER'S MOTHER WAS NOT ABLE TO COMPLETE THE READING SURVEY SINCE THE METER AND TEST STRIPS WERE NOT AVAILABLE DURING THE CALL. CUSTOMER'S MOTHER ALSO REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF CONVULSIONS AND LOSS OF CONSCIOUSNESS. CUSTOMER'S MOTHER REPORTED CUSTOMER DID NOT TAKE ANY DIABETES-RELATED MEDICATION, NON-PRESCRIPTION MEDICATION OR FOOD/DRINK TO COUNTERACT HER EVENT. ADC CUSTOMER SERVICES MADE MULTIPLE ATTEMPTS TO FOLLOW-UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION BUT WITHOUT ANY SUCCESS. THERE WAS NO REPORT OF ANY THIRD PARTY MEDICAL INTERVENTION, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL WITH ONGOING REANIMATION. THE ECG SHOWED PACING SPIKES BUT NO CAPTURE. SEVERAL ATTEMPTS TO REANIMATE THE PATIENT WERE UNSUCCESSFUL. THE DEVICE WAS INTERROGATED POST MORTEM AND WAS FOUND IN BACKUP VVI MODE. THE PHYSICIAN DOES NOT CONSIDER THE INCIDENT TO BE CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1572/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death V-193 (B) (4)