BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCRA CRT-P

    MDR report key: 3121955 · Received May 21, 2013

    Report

    Report Number
    9614453-2013-01056
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). A 5076 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2013. A 5076 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2013. A 3830 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT, WHO WAS ENROLLED IN THE (B)(6) CLINICAL STUDY, PRESENTED TO THE EMERGENCY ROOM WITH LEFT SIDED RIB PAIN FIVE DAYS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. A CHEST XRAY SHOWED BLUNTING OF THE COSTOPHRENIC ANGLE AND THE PATIENT WAS ADMITTED FOR OBSERVATION. A REPEAT CHEST XRAY TWO DAYS LATER NOTED A ¿WHITE OUT ON THE LEFT LUNG FIELD.¿ A NEEDLE ASPIRATION CONFIRMED A HEMOTHORAX. THE PATIENT IS REPORTED TO HAVE HAD A CARDIAC ARREST WITH UNSUCCESSFUL RESUSCITATION AND DIED. ADDITIONAL INFORMATION RECEIVED NOTED THAT NO BLOOD WAS PRESENT IN THE PERICARDIUM AND THAT HEMOTHORAX WAS ¿MOST LIKELY¿ CAUSED BY CONTINUED OOZING FROM SUBCLAVIAN INSERTION SITE FOLLOWED BY DETERIORATION ASSOCIATED WITH ANTIBIOTIC CAUSING AN INCREASED INR LEVEL. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ENLARGEMENT, LEFT HEMOTHORAX FOLLOWING RECENT PACER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224961 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death| H| L| R