BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 3053353 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05278
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 15, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN IMPEDANCE MEASUREMENTS OF MORE THAN 500 OHMS TO 1270 OHMS AND HIGH THRESHOLD MEASUREMENTS. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. THE LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156421 ENDOTAK DSP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 1640| 0125