BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 1862221 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16032
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD WAS CAPPED AND ABANDONED, SO WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION, THAT DURING THE EXPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE SET SCREWS ON THE ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PHYSICIAN OVERLOOKED ONE ATRIAL SET SCREW, AND ENDED UP PULLING THIS RIGHT ATRIAL (RA) LEAD APART. THE CONNECTOR WAS STUCK IN THIS EXPLANTED CRT-D HEADER. A NEW RA LEAD HAD TO BE IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1