BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2609831 · Received June 11, 2012

    Report

    Report Number
    2649622-2012-07013
    Event Type
    Injury
    Date Received
    June 11, 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 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) THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER TUBING WAS TORN, THE OUTER INSULATION HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS STRETCHED. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS TWO PATIENT ALERTS FOR RV. PACE LEAD IMPEDANCE > 2000 OHMS OCCURRED ON (B)(6)-2012 03:00:06 AND (B)(6)-2012 03:00:07. THE DAILY PACE IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR V.PACE = 480 TO INF (UN-FILTERED DATA) OHMS PEAK BETWEEN (B)(6)-2012. INTERFERENCE/NOISE WAS NOTED AS VENTRICULAR SHORT INTERVAL COUNT (V-SIC) WAS 28.1 COUNTS AVG/DAY, IN 2.78 DAYS, BETWEEN (B)(6)-2012 22:20:11 AND (B)(6)-2012 16:00:11. (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA. (B)(4) COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) IMPEDANCE - HIGH RESISTANCE/IMPEDANCE. (B)(4) 2 - PATIENT ALERTS FOR RV. PACE LEAD Z > 2000 OHMS ON (B)(6)-2012 03:00:06 AND (B)(6)-2012 03:00:07. DAILY PACE IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR V.PACE = 480 TO INF (UN-FILTERED DATA) OHMS PEAK BETWEEN (B)(6) -2012. (B)(4) SENSING - INTERFERENCE/NOISE. (B)(4) VENTRICULAR SHORT INTERVAL COUNT V-SIC=28.1 COUNTS AVG/DAY, IN 2.78 DAYS, BETWEEN (B)(6)-2012 22:20:11 AND (B)(6)-2012 16:00:11. (B)(4) DISTAL CONDUCTOR FRACTURED. (B)(4) FULL LEAD IN SEGMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR HIGH IMPEDANCE AND OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THERE WAS ALSO NO CAPTURE ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR HIGH IMPEDANCE AND OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THERE WAS ALSO NO CAPTURE ON THE LEAD. THE LEAD WAS 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
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB