BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4139017 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16324
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED WITH THE STYLET FULLY INSERTED. SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN WITH DRAG MARKS NOTED ON THE TERMINAL RING. THE HELIX WAS FULLY EXTENDED WITH BOTH DRIED BLOOD AND TISSUE NOTED ON THE HELIX; BLOOD INFILTRATION INTO THE HELIX HOUSING. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED OBSERVATIONS AND THE MELTING FOUND IN BOTH THE STYLET AND LEAD NEAR THE DISTAL TIP INDICATE THAT THE LEAD CAME IN CONTACT WITH A HEAT SOURCE, MOST LIKELY AFTER IT WAS EXPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER PRESENTED WITH PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. IT WAS ALSO NOTED THAT THE DEVICE BATTERY HAD REACHED END OF LIFE (EOL). THE PATIENT IS NOT PACEMAKER DEPENDENT SO THE LOSS OF CAPTURE DID NOT RESULT IN ANY ADVERSE PATIENT EFFECTS. A REVISION WAS PERFORMED AND IT WAS DISCOVERED DURING TESTING THAT THE RIGHT VENTRICULAR (RV) LEAD COULD ONLY PACE IN UNIPOLAR MODE. BOTH THE DEVICE AND RV LEAD WERE EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620053 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7742| J275