BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790278 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14718
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 FOR (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN EQUAL TO 210 MS BETWEEN (B)(4) 2012. THE SAVE TO DISK REVIEW REVEAL THE LEAD INTEGRITY ALERT TRIGGERED WITH PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD ELECTROGRAMS. THE LEAD INTEGRITY ALERT TRIGGERED FOR THE RV LEAD. THE NOISE FOR THE RA LEAD WAS FROM ELECTROMAGNETIC INTERFERENCE. THE RV LEAD ALSO HAD SOME HIGH FREQUENCY OVERSENSING. IT WAS NOTED THAT THE PATIENT COULD NOT IDENTIFY WHAT THEY MAY HAVE BEEN DOING OR WHAT COULD BE THE POSSIBLE CAUSE OF THE INTERFERENCE, BUT IT WAS PRESUMED TO BE FROM THE SAME SOURCE. THE RA AND RV LEADS 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
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 4193 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB