BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR RF

    MDR report key: 5503023 · Received March 15, 2016

    Report

    Report Number
    2938836-2016-01996
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. FINAL ANALYSIS FOUND THE REPORTED SHORT ERI TO EOS MARGIN WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE NOTED A SHORT ERI TO EOS MARGIN. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE SHORT ERI TO EOS MARGIN COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITING A SHORT ERI TO EOL MARGIN. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156457 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2207-36 2728892

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention