BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1874702 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05410
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 25, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT, THE PHYSICIAN WAS UNABLE TO RETRACT THE SUPERIOR VENA CAVA (SVC) SET SCREW. THE DEVICE WAS NOT 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention