BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 3153658 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06157
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: D354TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2011; 6935 IMPLANTABLE TACHY LEAD (B)(6) 2011; 5076 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A VENTRICULAR TACHYCARDIA STORM THE PATIENT PRESENTED TO THE HOSPITAL AND ON INTERROGATION IT WAS FOUND THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD/NO CAPTURE. CHEST X-RAY CONFIRMED DISLODGEMENT OF THE LEAD INTO THE RIGHT ATRIUM. THE LEAD WAS EXPLANTED 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
    254165 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R