BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 1991789 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00288
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 16, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE GROMMET WAS DAMAGED.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT PROCEDURE, THE SUPERIOR VENA CAVA (SVC) COIL HAD HIGH IMPEDANCE VALUES ONCE IT WAS CONNECTED TO THE DEVICE. IT WAS FURTHER REPORTED THAT THE SVC AND RIGHT VENTRICULAR (RV) COILS WERE SUBSEQUENTLY SWITCHED WITHIN THE DEVICE'S CONNECTOR AND THEN THERE WERE HIGH IMPEDANCE MEASUREMENTS ON THE RV LEAD. IT WAS FURTHER REPORTED THAT THRESHOLD TESTING WAS CHECKED AND THE DEVICE WAS NOT ABLE TO DELIVER A SHOCK WHILE SENSING PROPERLY. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other