BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951179 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14237
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 17, 2014
    Report Date
    August 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A REVISION PROCEDURE WAS PERFORMED WHEREIN THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). HOWEVER, THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOSS OF CAPTURE (LOC) THAT LED TO ASYSTOLE GREATER THAN 2 SECONDS. THE PATIENT IS DEPENDENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ALSO NOTED THAT THE DEVICE WAS PROGRAMMED TO VVI AND HAD INTERMITTENT PREMATURE VENTRICULAR CONTRACTIONS (PVCS) ON PRESENTING ELECTROGRAM (EGM) AND THEN ADVISED TO BRING PATIENT FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE INDICATING THAT THE CAUSE OF LOC WAS NOT DETERMINED AND THEY WILL CONTINUE TO MONITOR IT. AT THIS TIME, THE RV LEAD AND CRT-D REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428005 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R H175| 0157| 5068| KSR901| 4517