BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1862784 · Received October 8, 2010

    Report

    Report Number
    2182208-2010-00733
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "I HAVE HEARD COMPLAINTS FROM THREE IMPLANTING PHYSICIANS THAT I WORK WITH AT (B)(6) IN (B)(6). THEY ALL COMPLAIN THAT THE STYLETS THAT ARE PACKAGED WITH CRDMLEADS LOSE THEIR SHAPE DURING IMPLANT AND THEY HAVE VOICED THEIR FRUSTRATION WITH THIS CHANGE IN THE PRODUCT." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE STYLET DRB MEDTRONIC, INC. 6054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other