BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871560 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17284
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND IT WAS DETERMINED THAT THE SETSCREW WAS NOT COMPLETELY TIGHTENED DOWN. THE RV LEAD WAS UNSCREWED AND RECONNECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. AN X-RAY WAS PERFORMED AND THE PHYSICIAN BELIEVED THAT THERE WAS A SETSCREW ISSUE. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention E110| 0157| 1861| 4086