BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 3152180 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01165
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "ACTIVE FIXATION MECHANISM COMPLICATES CORONARY SINUS LEAD EXTRACTION AND LIMITS SUBSEQUENT REIMPLANTATION TARGETS." J. INTERVENT. CARD. ELECTROPHYSIOL. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE LEAD WAS EXTRACTED DUE TO THE PATIENT HAVING AN INFECTION. THE LEAD WAS SUCCESSFULLY REIMPLANTED IN ANOTHER BRANCH OF THE HEART. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252946 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX RICE CREEK MFG 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R