BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921810 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12882
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AT MAXIMUM OUTPUTS WHEN PATIENT WENT IN FOR A ROUTINE CHECK. THE LEAD WAS REPORTED TO BE DISLODGED. AN RV LEAD REVISION WAS SCHEDULED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT AN X-RAY WAS PERFORMED AND FOUND OUT THAT SOME OF THE LEAD WAS SLACKED AND HAD PULLED BACK BUT THE TIP WAS IN PLACE. THE CLINIC DETERMINED IT TO BE A MICRODISLODGEMENT. FURTHER, THE RV LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399845 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0276

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R E140| 0276| 4457| 1194