BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY RF DR

    MDR report key: 6104749 · Received November 15, 2016

    Report

    Report Number
    2938836-2016-14262
    Event Type
    Death
    Date Received
    November 15, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWP
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TRANSPORTED TO A CATHETER LAB AFTER THE BLOOD PRESSURE DROPPED. WHILE IN CATHETER LAB, THE PATIENTS HEART RATE WAS FOUND PACING SLOWER THAN NORMALLY. THOUGH A TEMPORARY PACING WIRE WAS PLACED, THE PATIENT HAD GONE INTO CARDIAC ARREST. THE PATIENT WAS ADMINISTERED MEDICATIONS. THE PACEMAKER WAS INTERROGATED POST CATHETER VISIT AND THE RIGHT VENTRICULAR LEAD WOULD NOT CAPTURE. THE TEMPORARY WIRE WAS LEFT IN PLACE AS THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT AND A TEMPORARY PACING CATHETER WAS PLACED INSIDE THE BODY. NO FURTHER INTERVENTION WAS COMPLETED AS THE PATIENT EXPIRED. IT IS UNKNOWN IF THE DEATH WAS PRODUCT RELATED. THE SUSPICION IS THAT THE CAUSE WAS FROM A LARGE ANTERIOR WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754229 ASSURITY RF DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PM2240 A000006522

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death (B)(4)| (B)(4)