BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2203749 · Received August 11, 2011

    Report

    Report Number
    2183613-2011-00431
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S79
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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) REMOTE MONITOR BATTERIES ARE NOT INSTALLED PRIOR TO SHIPMENT. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    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 BY THE PATIENT THAT BEFORE INITIAL USE OF CARELINK MONITOR, THE BATTERIES WERE CHECKED AND THE BATTERY LEAKED FLUID. IT WAS FURTHER REPORTED THAT THREE OF THE BATTERIES WERE INSERTED CORRECTLY AND ONE WERE IN THE WRONG DIRECTION. THE PATIENT REPORTED THAT THESE ARE THE MONITOR ARRIVED WITH BATTERIES INSTALLED. THE PATIENT CLEANED UP THE FLUID AND SUCCESSFULLY SENT A TRANSMISSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT BEFORE INITIAL USE OF CARELINK MONITOR, THE BATTERIES WERE CHECKED AND THE BATTERY LEAKED FLUID. IT WAS FURTHER REPORTED THAT THREE OF THE BATTERIES WERE INSERTED CORRECTLY AND ONE WAS IN THE WRONG DIRECTION. THE PATIENT REPORTED THAT THE MONITOR ARRIVED WITH BATTERIES INSTALLED. THE PATIENT CLEANED UP THE FLUID AND SUCCESSFULLY SENT A TRANSMISSION. 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 PATIENT MONITORING INSTRUMENT DXY MEDTRONIC MILACA INC. 2490H ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other SEDR01 IMPLANTABLE PULSE GENERATOR| 4076X2 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PULSE GENERATOR| 4076X2 IMPLANTABLE PACING LEAD