BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000023-1999-00066

    MDR report key: 265430 · Received September 8, 1999

    Report

    Report Number
    6000023-1999-00066
    Event Type
    Injury
    Date Received
    September 8, 1999
    Date of Event
    April 15, 1999
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other 7075 IMPLANTABLE PULSE GENERATOR| 6957 IMPLANTABLE PACING LEAD