BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211649 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09286
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    July 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION NOTED THAT THE LEAD WAS RETURNED SEVERED AND IN TWO PIECES, SOME OF THE LEAD SEGMENTS MAY NOT HAVE BEEN RETURNED. ALL OF THE CONDUCTOR ENDS WERE CUT, AND THERE WERE SETSCREW MARKS NOTED ON ALL OF THE TERMINALS. THERE WAS STRETCHED AND DEFORMED CONDUCTOR COILS, AND THE EXTRACTION STYLET WAS STILL TUCK IN THE TIP OF THE LEAD WHEN RETURNED. THE HELIX WAS EXTENDED AND THERE WAS TISSUE AND BODILY FLUID IN THE LEAD. ANALYSIS COULD NOT CONFIRM THE CLINICAL DAMAGE BASED ON THE SEGMENTS THAT WERE RETURNED

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES OF GREATER THAN 2000 OHMS AND WAS FOUND TO BE FRACTURED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310996 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0158| 4518| H210| 4538| N141| 4087