BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 3210866 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08220
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 27, 2013
    Report Date
    November 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT ANOTHER LOW OUT-OF-RANGE (OOR) IMPEDANCE MEASUREMENT WAS NOTED, AS WELL AS SOME NOISE ON THIS RIGHT VENTRICULAR (RV) LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE PACING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM OVERSENSED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, HOWEVER, NO PACING INHIBITION OCCURRED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE ICD WAS ELECTIVELY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312016 ENDOTAK DSP IMPLANTABLE DEFIBRILLATION LEAD LWS BOSTON SCIENTIFIC CORPORATION 0125 218659

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R E102| 1860| 1762| 0125