BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2201567 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11133
    Event Type
    Injury
    Date Received
    August 11, 2011
    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 Location
    AU
    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 PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS FOUND NO ANOMALIES. THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED. SEVERAL CONDUCTORS WERE DISTORTED, STRETCHED WITH BLOOD/BODY FLUID (NOT OBSTRUCTED). THERE WAS A DEFIBRILLATOR CONDUCTOR FRACTURE (OVERSTRESS). THE INNER INSULATION AND OUTER TUBING WERE KINKED/BUCKLED. THE OUTER INSULATION AND OUTER TUBING OVERLAY WERE MELTED AND THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. ALL INSULATORS WERE BREACHED CUT. THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AFTER HEARING AN "ALARMTONE RINGING". INCREASED IMPEDANCE AND LOW SENSING FROM THE RIGHT VENTRICULAR (RV) LEAD WAS NOTICED. THE LEAD EXTRACTION WAS ATTEMPTED, THE LEAD WAS TORN AND NO NEW LEAD WAS IMPLANTED UNTIL THE FOLLOWING DAY WHEN THE LEAD WAS THEN EXPLANTED. IT WAS ALSO REPORTED THAT THE DEVICE WAS EXPLANTED. 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. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4592 IMPLANTABLE PACING LEAD