BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 4140058 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17160
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    November 6, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT-OF-RANGE (OOR) PACING IMPEDANCE OF GREATER THAN 2000 OHMS, AND NOISE. AS A RESULT A SURGICAL INTERVENTION WAS PERFORMED WHERE THERE WAS FOUND TO BE A POSSIBLE LOOSE SETSCREW. THE SETSCREW WAS TIGHTENED AND THAT APPEARS TO HAVE SOLVED THE ISSUES. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) WAS EXHIBITING INCREASED SHOCKING IMPEDANCE MEASUREMENTS. THE CALLER COULD NOT CONFIRM IF THE NOISE THAT WAS OBSERVED IN THE PAST WAS STILL BEING OBSERVED. A REVISION PROCEDURE WAS PERFORMED AND THIS RV LEAD WAS REMOVED FROM SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620349 ENDOTAK RELIANCE SG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0181 324139

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R E141| 0181