BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 4833821 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06939
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 23, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT ID: 5076-52 LEAD, IMPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION HAD A DEPRESSION BREACH. THERE WAS BLOOD ON A DEFIBRILLATION CONDUCTOR AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, AND THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. DURING THE WEEK (B)(6) 2015, RV COIL IMPEDANCE MEASURED 16382 OHMS UP FROM A TREND IN THE 50-70 OHM RANGE. DURING THE WEEK (B)(6) 2015, RV PACING IMPEDANCE MEASURED 16382 OHMS UP FROM A TREND IN THE 400-500 OHM RANGE. IMPEDANCES CONTINUED TO BE HIGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IMPEDANCE JUMP, SENSING AMPLITUDE DECREASE AND EXIT BLOCK ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO REPORTED THERE WAS THRESHOLD INCREASE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378895 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 69436536

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 7274 ICD