BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2810663 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03721
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. 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: "A SINGLE SHOCK DURING AN EPISODE OF VENTRICULAR TACHYCARDIA: IS THE DEVICE WORKING PROPERLY?" INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. (B)(4) 2012; 12(5):226-228.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO A SINGLE "NONSYNCOPAL" IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK. THE DEVICE HAD STORED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). INTERROGATION OF THE DEVICE DID NOT REVEAL ANY "ABNORMAL" PARAMETERS FOR SENSING AND PACING. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. D264DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R IMPLANTABLE TACHY LEAD