BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 3223557 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10586
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    March 10, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NOISE ALONG WITH INTERMITTENT OUT-OF-RANGE (OOR) IMPEDANCE ON DAILY MEASUREMENTS. NOISE COULD BE RECREATED ON A SHOCK CHANNEL WITH ISOMETRICS BUT THERE WAS NO NOISE OR OVERSENSING ON THE RV ELECTROGRAM (EGM). THE PHYSICIAN THOUGHT THAT THE LEAD IS GETTING OLD. ALSO, THE PHYSICIAN INCREASED THE DURATION IN VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) ZONES TO 10 SECONDS AND 5 SECONDS, RESPECTIVELY. THE PATIENT DID NOT RECEIVE THERAPY FOR NOISE AND THERE WERE NO PAUSES IN CARDIAC RHYTHM. BASED ON ADDITIONAL INFORMATION OBTAINED, THERE WAS A HIGH OUT-OF-RANGE (OOR) AND INTERMITTENT PACING LEAD IMPEDANCE. NO ADDITIONAL TESTING WAS PERFORMED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT THE CAN HAVE NOISE ON SHOCK EGM FROM MYOPOTENTIALS DUE TO THE SHOCK EGM IS A DISTAL COIL TO CAN - UNIPOLAR VECTOR ACROSS THE CHEST MIUSCLES. THIS PATIENT UNDERWENT SURGICAL INTERVENTION AND THE PRODUCT WAS SURGICALLY CAPPED AND ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324151 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 1762| 1860| E102| 0125