BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000023-1999-00076

    MDR report key: 265880 · Received November 12, 1999

    Report

    Report Number
    6000023-1999-00076
    Event Type
    Malfunction
    Date Received
    November 12, 1999
    Date of Event
    August 8, 1999
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TESTED OUT OF SPEC DURING MFG'S ANALYSIS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 6939 IMPLANTABLE TACHY LEAD| 6933 IMPLANTABLE TACHY LEAD| 7219D IMPLANTABLE PACEMAKER/CARDIO/DEFIB