BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790691 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14444
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. EVALUATION SUMMARY: (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED FROM A CLAVICLE-RIB CRUSH, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY MELTED, THE OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING BREACH/BREACH (NON-ELECTRICAL), THE OUTER INSULATION WAS TORN AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. IT WAS ALSO NOTED THAT THERE WAS A FLEXED CLAVICLE-RIB CRUSH. (B)(4) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 WAS RECORDED. THE PROGRAMMER DATA FILE (B)(4) SHOWS ONE ALERT EVENT FOR "RIGHT VENTRICULAR (RV) BIPOLAR LEAD IMPEDANCE GREATER THAN 3000 OHMS" ON (B)(4) 2012. VENTRICULAR SHORT INTERVAL COUNT (V-SIC) OF 32.7 COUNTS AVERAGE PER DAY, IN 4.74 DAYS, BETWEEN (B)(4) 2012. THERE WERE FIVE LEAD FAILURE PREDICTOR HIGH RATE OF NON-SUSTAINED OF 212 MS OR LESS IN AN AVERAGE VENTRICULAR CYCLE BETWEEN (B)(4) 2012. THERE WERE TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTORS ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME BY AMBULANCE AFTER HEARING AN ALARM TONE RINGING. THE PATIENT HAD HIGH RIGHT VENTRICULAR (RV) IMPEDANCE AND OVERSENSING. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT DURING THE EXTRACTION OF THE RV LEAD, THE LEFT VENTRICULAR (LV) AND THE RIGHT ATRIAL (RA) LEADS WERE ALSO EXTRACTED AS THE LEADS HAD ALL GROWN TOGETHER. THE RA LEAD WAS REPLACED AND THE LV LEAD WAS NOT REPLACED. NO PATIENT COMPLICATION HAS 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. 6948

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD