BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2457909 · Received February 16, 2012

    Report

    Report Number
    2182208-2012-00284
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    August 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. REFERENCED ARTICLE: "AN APPROPRIATE DEFIBRILLATION THRESHOLD OBTAINED BY THE COMBINED CONNECTION BETWEEN TWO SHOCK LEADS AND ICD GENERATOR." INTERN. MED. 2011;50(22):2815-2818. 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.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION ABOUT THE DEVICE AND LEAD. THE SINGLE-COIL DEFIBRILLATION SYSTEM WAS UNABLE TO TERMINATE THE INDUCED VENTRICULAR FIBRILLATION. THE SYSTEM WAS REVISED AND THE SYSTEM WAS THEN ABLE TO TERMINATE THE INDUCED VENTRICULAR FIBRILLATION. THE SYSTEM APPEARS TO REMAIN IN USE. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. D234DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 5554 IMPLANTABLE PACING LEAD