BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053654 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05396
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED TWO SETS OF SETSCREW MARKS ON THE IS-1 TERMINAL CONNECTOR. ONE SET INDICATED THE LEAD WAS FULLY INSERTED INTO THE HEADER, THE OTHER INDICATED INADEQUATE INSERTION INTO THE HEADER. ANALYSIS INDICATED THAT INADEQUATE INSERTION WOULD CAUSE ELECTRICAL ANOMALIES. ANALYSIS ALSO REVEALED THAT THE RS- COIL WAS FRACTURED. THE DAMAGE WAS APPROXIMATELY 26.2 CENTIMETERS (CM) FROM THE IS-1 TERMINAL PIN WHICH IS 2 CM FROM THE SUTURE SLEEVE TIE DOWN. THIS TYPE OF FRACTURE IS CONSISTENT WITH A FATIGUE FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE PACE/SENSE CHANNEL. THE IMPEDANCE AND SENSING MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE EPISODES OF NOISE WERE NON-SUSTAINED; THEREFORE, NO THERAPY WAS GIVEN AS A RESULT. THE PATIENT REQUESTED THAT THE LEAD BE EXPLANTED WITH NO REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154530 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0137

    Patients

    Seq Age Sex Outcome Treatment
    1 10123 DA Hospitalization| L| R T177| 4461| 6943| A155| 1851| 0137