BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 4160978 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02766
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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: INCIDENCE OF NONPHYSIOLOGIC SHORT VV INTERVALS DETECTED BY THE SENSING INTEGRITY COUNTER WITH INTEGRATED BIPOLAR COMPARED WITH TRUE BIPOLAR LEADS: CLINICALLY INCONSEQUENTIAL OR CAUSE FOR CONCERN? J. INTERVENT. CARD. ELECTROPHYSIOL. 2014;39(3):281-285. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD MODEL. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: HIGH IMPEDANCE, OVERSENSING, AND INAPPROPRIATE SHOCKS. THE STATUS OF SOME OF THE LEADS IS UNKNOWN, HOWEVER SOME OF THE LEADS WERE REPORTED AS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642486 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R