BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 4160651 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11803
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT MEDICAL PRODUCTS: ADDR06 IPG, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. THE LEAD HAD LOST SLACK AS THE PATIENT HAD GROWN. THE LEAD WAS CAPPED 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
    641475 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4011

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R 6957J LEAD