BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2864857 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00250
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 12, 2012
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DEVICE SET SCREW WAS IN THE CONNECTOR BORE. MICROSCOPIC INSPECTION REVEALED NO DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR LEAD COULD NOT BE CONNECTED BY THE DEVICE SCREW. THE PHYSICIAN FELT THAT THE SCREW WAS LOOSENED. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR LEAD COULD NOT BE CONNECTED BY THE DEVICE SCREW. THE PHYSICIAN FELT THAT THE SCREW WAS LOOSENED. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR