BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1920795 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02153
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE HAS BEEN ANALYZED AND REVEALED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010. HIGH RESISTANCE/IMPEDANCE WAS NOTED WITH ABRUPT INCREASE FOR VENTRICULAR PACE BIPOLAR IMPEDANCE OF 551 TO A PEAK OF 1197 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010. OVERSENSING WAS REVEALED WITH 7 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2010. 1 VENTRICULAR FIBRILLATION EPISODE OF 140 MS ON (B)(6) 2010. INTERFERENCE/NOISE WAS INDICATED WITH VENTRICULAR SENSING INTEGRITY COUNTER OF 129.1 COUNTS AVERAGE/DAY, WITHIN 0.43 DAYS BETWEEN (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO LEFT VENTRICULAR STIMULATION POSSIBLE AFTER THE LEAD WAS CONNECTED, NO CAPTURE WAS OBSERVED, AND THERE IS A POSSIBLE CONNECTOR ISSUE. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R