BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 2913799 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00127
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 WAS REPORTED THAT THIS PATIENT WAS RELEASED FROM THE HOSPITAL. THE LOSS OF CAPTURE DID NOT RESULT IN GREATER THAN TWO SECONDS OF ASYSTOLE AS THE PATIENT IS NOT DEPENDENT. NO FURTHER INTERVENTION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCES GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. THE PATIENT WAS ADMITTED DUE TO COMPLAINT OF FEELING A SHOCK. HOWEVER, NO SHOCK WAS RECORDED. THERE HAS BEEN NO REPORT OF A SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19774 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0185
    19790 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Life Threatening| H 0185| 4470| A155| E102| 0185| 4470| E102| A155