BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2813142 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16500
    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
    IN, 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. EVALUATION SUMMARY (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS OVERSENSING WITH FIFTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE LESS THAN OR EQUAL TO 210 MILLISECONDS BETWEEN (B)(4)-2010 AND (B)(4)-2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED FOR T-WAVE OVERSENSING. THE AVAILABLE ELECTROGRAMS WERE EVALUATED AND NO T-WAVE OVERSENSING WAS NOTED. THE PHYSICIAN THEN DECIDED TO CHANGE OUT THE DEVICE TO A NEW DEVICE TO PROVIDE INTEGRATED BIPOLAR SENSING AND T-WAVE ALGORITHM. DURING THE PROCEDURE, THE PATIENT HAD VENTRICULAR FIBRILLATION WHILE CAUTERY WAS OCCURRING. THERE IS POSSIBLE DAMAGE INSIDE THE GROMMET FROM THE CAUTERY. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD IS STILL IN USE. 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 55 YR Hospitalization| L| R