BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 4831619 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05449
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE GENERATOR REPLACEMENT, THE PHYSICIAN WAS PULLING THE LEAD OUT OF THE DEVICE AND THE LEAD BODY INSULATION NEAR THE PIN SEPARATED. THE PHYSICIAN REPAIRED THE LEAD WITH MEDICAL ADHESIVE AND ANCHORING SLEEVES. THE LEAD TESTED FINE THROUGH THE ANALYZER AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379113 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 401158

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R ADSR06 (B)(6) 2008