BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2952559 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00606
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    January 18, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THE LEAD INTEGRITY ALERT TRIGGERED. TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012. INTERFERENCE/NOISE WAS NOTED. VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 42862 COUNTS, IN 2.75 DAYS, OCCURRED BETWEEN (B)(6) 2012. OVERSENSING ALSO OCCURRED. 13 VENTRICULAR NON-SUSTAINED EPISODES OF LESS THAN OR EQUAL TO 215 MS OCCURRED ON (B)(6) 2012. LEAD FAILURE PREDICTOR HIGH RATE NON-SUSTAINED EPISODES OF LESS THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2012. VENTRICULAR FIBRILLATION (VF) EPISODES OF 190 MS AVERAGE V-CYCLE OCCURRED ON (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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE AND T WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. A LEAD INTEGRITY ALERT (LIA) TRIGGERED. IT WAS ALSO NOTED THAT THERE WAS A LEAD WARNING FOR HIGH PACE/SENSE IMPEDANCE, AND CAPTURE THRESHOLDS WERE HIGH. FRACTURE OF THE RV LEAD WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE DEVICE ALGORITHM INITIALLY WITHHELD FOR NOISE BUT TIMEOUT OCCURRED AND A SHOCK WAS DELIVERED. THE LEAD WAS CAPPED AND REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57447 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR