BEUDAMED
    FDA Adverse Event Injury Summary report: N

    META MV

    MDR report key: 151737 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01071
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    March 6, 1997
    Report Date
    June 20, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES SENSING DIF FICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 META MV Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY TELECTRONICS PACING SYSTEMS INC 1202 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention