BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812260 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16920
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PERFORMANCE DATA RETRIEVED FROM THE DEVICE CONNECTED TO THE LEAD WAS REVIEWED. A PATIENT ALERT FOR HIGH LEAD IMPEDANCE WAS FOUND TO HAVE BEEN ISSUED ON (B)(6) 2012 DURING THE REVIEW OF DATA. WEEKLY IMPEDANCE LOG DATA SHOWED VARIOUS SPIKE INCREASES FOR IMPEDANCE BETWEEN 43-184 OHMS BETWEEN (B)(6) 2011 AND (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VARYING IMPEDANCE. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB