BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 2202173 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01204
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/102
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION NOTE: THIS COMPLAINT WAS INADVERTENTLY SUBMITTED UNDER THE MEDICAL DEVICE REPORTING REGULATIONS, AS THE POTENTIAL FOR INJURY IS NOT LIKELY FOR THIS TYPE OF EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. 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 THE CLINICIAN WAS RECEIVING AN ERROR MESSAGE, WHILE ATTEMPTING TO ADD A NEW PATIENT TO CARELINK, THAT THE DEVICE WAS ALREADY ENROLLED. THE SERIAL NUMBER HAD BEEN ASSOCIATED TO ANOTHER ENROLLED PATIENT MISTAKENLY. TO CORRECT THIS ERROR THE REGISTRATION DATABASE NEEDED TO BE UPDATED. THIS WOULD DELAY THE ENROLLMENT OF THIS PATIENT ONE TO TWO DAYS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN WAS RECEIVING AN ERROR MESSAGE, WHILE ATTEMPTING TO ADD A NEW PATIENT TO CARELINK, THAT THE DEVICE WAS ALREADY ENROLLED. THE SERIAL NUMBER HAD BEEN ASSOCIATED TO ANOTHER ENROLLED PATIENT MISTAKENLY. TO CORRECT THIS ERROR THE REGISTRATION DATABASE NEEDED TO BE UPDATED. THIS WOULD DELAY THE ENROLLMENT OF THIS PATIENT ONE TO TWO DAYS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK SYSTEM SOFTWARE NVZ MEDTRONIC, INC. CARELINK CONGO ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other