BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3860592 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05384
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT EVENT SUMMARY #6942-65: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND A HIGH IMPEDANCE. A POSSIBLE FRACTURE WAS SUSPECTED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED BY A PACE/SENSE LEAD. THE RV SHOCKING COILS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341756 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R D224VRC ICD