BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3926002 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15367
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 6, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND CHEST DISCOMFORT UPON DEEP RESPIRATION. ON (B)(6) 2013, THE PATIENT HAD A CARDIAC TAMPONADE. AN ECHOCARDIOGRAM REVEALED PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED. A CHEST X-RAY INDICATED THAT THE ATRIAL LEAD HAD PERFORATED THE ATRIUM. THE PATIENT STABILIZED AND THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2013. THE PATIENT WAS MONITORED CLOSELY AND NO FURTHER SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403268 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention