BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT FIDELIS

    MDR report key: 1862869 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10505
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED T-WAVE OVERSENSING AND SHORT V-V INTERVALS WHICH LED TO INAPPROPRIATE SHOCKS. IT WAS LATER REPORTED BY THE PATIENT THAT HIS LEAD BROKE. THE LEAD WAS CUT, CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED T-WAVE OVERSENSING AND SHORT V-V INTERVALS WHICH LED TO INAPPROPRIATE SHOCKS. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS ASKU LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD