BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3923412 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14695
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    February 10, 2012
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PNEUMOTHORAX OCCURRED DURING IMPLANT OF THE RIGHT VENTRICULAR LEAD; DRAINAGE WAS PERFORMED. ON (B)(6) 2012, A PERFORATION WAS REVEALED BY COMPUTED TOMOGRAPHY SCAN. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399302 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention