BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1992313 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02761
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. 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. FOUR PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(4)-2010. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT SPIKE INCREASE FOR MAX RV PACE=464 TO 4336 OHMS MAX BETWEEN (B)(4)-2010, THEN RETURNS TO BASELINE AT 664 OHMS ON (B)(4)-2011.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD FRACTURED AND IT OCCURRED RIGHT AFTER AN OPEN HEART SURGERY. A NEW LEAD WAS ADDED FOR PACING AND SENSING AND THE HIGH VOLTAGE PORTION OF THE LEAD REMAINED IN USE. FIVE DAYS LATER THE RV LEAD WAS REPAIRED NOTING IT HAD SOME SHARP BENDS IN IT. WHEN THE POCKET WAS OPENED IT WAS FOUND TO BE INFECTED THUS THE PATIENT WOULD BE TREATED WITH ANTIBIOTICS. THE LEAD WAS SUBSEQUENTLY REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD