BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK SQ

    MDR report key: 1851923 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14739
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED, AND THE LEADS WERE LEFT IMPLANTED. OF NOTE, THE DEVICE WAS REPORTEDLY NOT PROGRAMMED OFF ONCE EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THESE OBSERVATIONS. THE PATIENT HAS NOT RECEIVED A NEW SYSTEM. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT DEVELOPED A POCKET INFECTION. THE PATIENT'S LEADS INCLUDE A SUBCUTANEOUS ARRAY (SQA) DEFIBRILLATION LEAD AND AN OEM MANUFACTURED RIGHT VENTRICULAR (RV) LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0085

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R 0185| E102| 4046| 0085