BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2131666 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03532
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2009. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS HIGH IMPEDANCE FOR MAX RV PACE= 1632 TO INFINITE OHMS RANGE UN-FILTERED DATA, BETWEEN (B)(6) 2009 AND (B)(6) 2011. EIGHT - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2009 23:46:53 AND (B)(6) 2009 00:11:00. ONE - VF=210 MS ON (B)(6) 2009 23:47:57. VENTRICULAR SHORT INTERVAL COUNT V-SIC=59.9 COUNTS AVG/DAY, IN 14.77 DAYS, BETWEEN (B)(6) 2011 22:03:32 AND (B)(6) 2011 16:36:14.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT DEVICE WAS "DOUBLE COUNTING AND AS A RESULT DELIVERED A SHOCK THERAPY" AND HAD IMPEDANCE SPIKES. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 62 YR Hospitalization| L| R 6948 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD