BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2122286 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07849
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0067-0070-2008
    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): A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS FRACTURED DUE TO OVERSTRESS, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WERE VOIDS IN THE OUTER INSULATION BILUMEN TUBING, THE OUTER INSULATION WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED HIGH RESISTANCE/IMPEDANCE. THERE WAS ONE PATIENT ALERT FOR RIGHT VENTRICULAR (RV) PACE LEAD IMPEDANCE ON (B)(6) 2011 AT GREATER THAN 3000 OHMS. THIS IS ALSO OBSERVED AT A SUDDEN RISE IN IMPEDANCE BETWEEN (B)(6) 2011 AND (B)(6) 2011 IN THE PACING WEEKLY MEASUREMENT LOG. ANALYSIS RESULTS ALSO NOTED INTERFERENCE/NOISE. HIGH VENTRICULAR SHORT INTERVAL COUNT (SIC) EPISODES COUNTS ARE OBSERVED WITH 340 COUNTS OCCURRING BETWEEN (B)(6) 2011 AND EXPLANT THE NEXT DAY. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM. ANALYSIS RESULTS ALSO REVEALED OVERSENSING. MULTIPLE SHORT V-V SENSED EVENTS OF LESS THAN 220 MS ARE OBSERVED ON (B)(6) 2011 (45 EPISODES O NONSUSTAINED TACHYCARDIA AND ONE EPISODE OF VENTRICULAR FIBRILLATION). THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, THE PHYSICIAN RECOGNIZED A SUDDEN RISING OF IMPEDANCE AND THE SHORT INTERVAL COUNTER VALUE WAS HIGH ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS IMMEDIATELY SENT TO THE INTENSIVE CARE UNIT OF THE HOSPITAL. DUE TO AN EXIT BLOCK OF THE RV LEAD, THE PATIENT HAD TO BE "REANIMATED". AN EXTERNAL PACER WAS USED AND THE LEAD REVISION TOOK PLACE. NO FURTHER 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. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB