BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1945870 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21291
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Removal / Correction Number
    Z-1144/1145-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IN SERVICE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD INDICATED THAT HIS LEAD WAS ABOUT THE FRACTURE DUE TO HIGH IMPEDANCE MEASUREMENTS. THE PATIENT DID NO SPECIFY WHICH LEAD WAS ABOUT TO FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)