BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 1802658 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08732
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    K080428
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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): ATTAIN COMMAND SHAFT WAS FLATTENED; DAMAGED AT IMPLANT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO BE INTRODUCED, AND APPEARED THINNER THAN NORMAL. A DIFFERENT CATHETER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN COMMAND LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC PUERTO RICO, INC. 6250C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other