BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3357242 · Received September 19, 2013

    Report

    Report Number
    2182208-2013-02598
    Event Type
    Injury
    Date Received
    September 19, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: UNINTENDED HARM AND BENEFIT OF THE IMPLANTABLE DEFIBRILLATOR IN AN UNFORTUNATE (B)(6)YEAR-OLD MALE: FEATURING A SEQUENCE OF RARE LIFE-THREATENING COMPLICATIONS OF CARDIAC PROCEDURES. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. JULY 1 2013;13(4):151-156. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. POST IMPLANTATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT COMPLAINED OF PLEURITIC CHEST PAIN AND AN ECHOCARDIOGRAM REVEALED MILD PERICARDIAL EFFUSION. THE PATIENT WAS DIAGNOSED AS HAVING DEVICE PERICARDITIS AND WAS TREATED WITH MEDICATION. TWO WEEKS LATER THE PATIENT HAD A RELAPSE FOLLOWING CESSATION OF THERAPY. ECHOCARDIOGRAM REVEALED A LARGE PERICARDIAL EFFUSION WITH SIGNS OF TAMPONADE. THE PATIENT WAS TREATED WITH STEROID THERAPY AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473299 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Hospitalization| R