BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYROX PX 60-BP

    MDR report key: 1140252 · Received August 29, 2008

    Report

    Report Number
    1028232-2008-01055
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    May 6, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD WERE TESTED AS PART OF THE ANALYSIS. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE CUTS IN THE LEAD BODY PROBABLY STEM FROM THE EXPLANATION PROCESS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MFG ERRORS.

    Description of Event or Problem · 1

    OUS MDR. AN INTERMITTENT EXIT BLOCK WAS REPORTED ONE DAY AFTER THE IMPLANTATION. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYROX PX 60-BP PACER LEAD DTB BIOTRONIK GMBH AND CO 120307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization