BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131900 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00925
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 20, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STICKERS WITH SERIAL NUMBERS AND MODEL NUMBERS FROM PROTECTA DEVICES THAT DO NOT SPECIFY THE NAME PROTECTA OR PROTECTA XT. THIS IS LEADING TO A LOT OF CONFUSION ON PATIENT IDENTIFICATION CARDS AND IMPLANT BOOKS FOR DOCTORS AND PHYSIOLOGIST. CUSTOMER BELIEVES IT IS A SAFETY ISSUE AS MODEL NUMBERS ARE SO SIMILAR. THIS IS COMPLAINT ABOUT PACKAGING LABELING. THE DEVICE STATUS IS NOT APPLICABLE FOR THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STICKERS WITH SERIAL NUMBERS AND MODEL NUMBERS FROM PROTECTA DEVICES THAT DO NOT SPECIFY THE NAME PROTECTA OR PROTECTA XT. THIS IS LEADING TO A LOT OF CONFUSION ON PATIENT IDENTIFICATION CARDS AND IMPLANT BOOKS FOR DOCTORS AND PHYSIOLOGIST. CUSTOMER BELIEVES IT IS A SAFETY ISSUE AS MODEL NUMBERS ARE SO SIMILAR. THIS IS A COMPLAINT ABOUT PACKAGING LABELING. THE DEVICE STATUS IS NOT APPLICABLE FOR THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other