BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 3071645 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05225
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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. 8042B IMPLANTABLE PULSE GENERATOR 2007 (B)(6); 4011 IMPLANTABLE PACING LEAD 4194 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAS A KNOWN HISTORY OF OVERSENSING. THERE WERE MANY ATRIAL HIGH RATE (AHR) EPISODES SOME WITH TRENDING AND OTHERS WITHOUT TRENDING. THE LEAD REMAIN 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
    173081 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 451153

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR