BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 2905503 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13302
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD SEGMENTS WERE THOROUGHLY ANALYZED. THE SEGMENTS OF THE LEAD HAD ALREADY BEEN REMOVED FROM THE HEADER OF THE DEVICE DURING DEVICE LABORATORY ANALYSIS. IT WAS DETERMINED THAT THE CLINICAL OBSERVATION WAS DUE TO SILICONE TO SILICONE BONDING OF THE LEAD SEAL RING TO THE INNER SEALS IN THE HEADER OF THE DEVICE. NO FURTHER ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE PULSE GENERATOR CHANGE OUT PROCEDURE THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE UNABLE TO BE REMOVED FROM THE DEVICE HEADER. ALL FOUR SET SCREWS WERE REPORTED TO HAVE BEEN STUCK. BOTH LEADS WERE CUT AND CAPPED. THE DEVICE IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11191 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 4261| 0950| 2360L| 1291| 4269