BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS

    MDR report key: 152288 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01304
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    June 6, 1997
    Report Date
    July 30, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES PROBABLE LEAD FRACTURE AND THAT THE PATIENT FELT PAIN IN THE A REA OF THE IMPLANTED PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS Implant PERMANENT PACEMAKER ELECTRODE DTB PACESETTER INC. 1136T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention