BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3301135 · Received August 21, 2013

    Report

    Report Number
    2182208-2013-02568
    Event Type
    Injury
    Date Received
    August 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    August 2, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: "UNDERDETECTION OF VENTRICULAR FIBRILLATION DESPITE ICD TESTING AND HIGH SINUS R WAVE." HERZSCHRITTMACHERTHER. E LEKTROPHYSIOL. JUNE 1 2013;24(2):131-135. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE FAILURE MODES NOTED IN THE ARTICLE WERE OVERSENSING AND UNDERSENSING. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT. THE STATUS IS UNKNOWN, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406956 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Hospitalization| L| R