BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2050626 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05391
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. EVENT DESCRIPTION NOTES LIA (LEAD INTEGRITY ALERT) TRIGGER; HOWEVER, S2D FILE NOTES THAT LIA RAMWARE IS NOT INSTALLED. NO LIA TRIGGER IS OBSERVED. ONE SHORT V-V SENSED EVENT OF < 220 MS IS OBSERVED ON THE (B)(6) 2011. (1 EPISODES NST). RV PACE LEAD RECORDED A PATIENT ALERT ON (B)(6) 2011 AT >3000 OHMS. TREND UP TO THAT POINT SHOWS A BASELINE OF APPROXIMATELY 500 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAS VARYING IMPEDANCE, HIGH IMPEDANCE SPIKES, OVERSENSING, AND THE PATIENT ALERT FOR LEAD INTEGRITY WAS TRIGGERED. THE LEAD REMAINS 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
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB