BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2813186 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17226
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THE SAVE TO DISK NOTED LEAD IMPEDANCE PACING RIGHT VENTRICULAR TREND RISING. WEEKLY PACE IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MIN AND MAX RV PACE EQUAL TO 368 TO 2848 OHMS RANGE BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWED IMPEDANCE TRENDS BETWEEN 300 OHMS AND 2500 OHMS FOR THE LAST 14 MONTHS. THE SHORT INTERVAL COUNTER ALSO INCREASED. THE LEAD WAS REPLACED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R