BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 2964512 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02084
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2002; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT, THE PATIENT HAD STIMULATION AND THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE PHYSICIAN EXPLANTED THE LEAD, AND IMPLANTED A NEW LEAD IN A DIFFERENT LOCATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT, THE PATIENT HAD STIMULATION AND THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE PHYSICIAN EXPLANTED THE LEAD, AND IMPLANTED A NEW LEAD IN A DIFFERENT LOCATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67960 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC