BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1992475 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00185
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "VENTRICULAR OVERSENSING DUE TO MANUFACTURER-RELATED DIFFERENCES IN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR SIGNAL PROCESSING AND SENSING LEAD PROPERTIES." EUROPACE. OCTOBER 1;12(10):1460-1466.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. IT WAS REPORTED THAT THERE WAS R-WAVE DOUBLE-SENSING NOTED ON THIS LEAD. THE ARTICLE REPORTS THAT THIS WAS RESOLVED AFTER REPROGRAMMING. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. 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 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6942 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R