BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2368509 · Received December 12, 2011

    Report

    Report Number
    6000144-2011-06934
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    September 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)96) 2010. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE AND SPIKE INCREASES FOR MAXIMUM RIGHT VENTRICULAR (RV) PACE = 576 TO 2384 OHMS WITH RANGES BETWEEN (B)(6) 2010 AND (B)(6) 2011. THERE WAS A BATTERY VOLTAGE LONG CHARGE TIME, NOT ELECTIVE REPLACEMENT INDICATOR (ERI) (TACHY). ONE PATIENT ALERT TRIGGERED FOR AN EXCESSIVE CHARGE TIME ON (B)(6) 2011. THE PROGRAMMER DATA S2D FILE _983000 SHOWS THAT THE DEVICE REACHED END OF LIFE (EOL) ON (B)(6) 2011, WITH A CHARGE TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWS TO BE AT EOL (END OF LIFE) AND THAT THE DEVICE HAD ONE LONG CHARGE TIME OF GREATER THAN SIXTEEN SECONDS. THE DEVICE WAS REMOVED 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 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 6945 IMPLANTABLE TACHY LEAD| 6940 IMPLANTABLE PACING LEAD