BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIX

    MDR report key: 2951413 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00113
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 4, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) 2012 (B)(6).

    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, THE PATIENT DEVELOPED ENDOCARDITIS. THE DEVICE AND LEADS WERE REMOVED, THE DEVICE POCKET CULTURED AND ANTIBIOTIC TREATMENT WAS "NECESSARY." THE DEVICE WILL BE RETURNED, THE LEADS WILL NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55540 SUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5072

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 4092-58 IMPLANTABLE PACING LEAD