BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, SJ4 CONNECTOR

    MDR report key: 1831132 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03578
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    March 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THE PATIENT HAD A POCKET INFECTION THAT DUE TO NONCOMPLIANCE, AND PROGRESSED INTO AN ERODED POCKET. THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 7120Q/58, (B)(4), 1888TC/46, (B)(4)