BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3051048 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04752
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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: 7289 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2008, 4193 LEFT VENTRICULAR (LV) LEAD (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP RESULTS INDICATED THE LEAD WAS CAPPED AND REPLACED DUE TO FAILURE TO CAPTURE AND HIGH THRESHOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD WAS DETERMINED UNUSABLE. THE LEAD WAS CAPPED AND REPLACED. FOLLOW ATTEMPTS HAVE REVEALED NO FURTHER INFORMATION REGARDING THE REASON THE LEAD WAS DETERMINED UNUSABLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148270 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD