BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 3062688 · Received April 17, 2013

    Report

    Report Number
    2649622-2013-05123
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED 2008 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT'S LEAD "BROKE IN HALF". THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164216 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| R