BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1802803 · Received August 17, 2010

    Report

    Report Number
    2183613-2010-00150
    Event Type
    Injury
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. FURTHER INVESTIGATION BY THE BIOMEDICAL ENGINEERING DEPARTMENT SHOWED A CRACK IN THE TOP LEFT SIDE OF THE CASE, A HOLE IN THE BOTTOM IN THE PLASTIC IN THE JOIN OF THE TOP AND BOTTOM CASES, AND IT APPEARED THE BOTTOM SCREW WAS NOT HOLDING, AS THE INTERNAL POST WAS SNAPPED OFF THE CASE. THE DEVICE APPEARED TO HAVE BEEN DROPPED AT SOME STAGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORT OF THE BATTERY DRAWER BEING HARD TO OPEN. THE BATTERY DRAWER AND BATTERY RELEASE WERE CONTAMINATED AND THE BATTERY CONTACTS COMPRESSED. THE UPPER AND LOWER CASES AND SIDE BAIL COVERS WERE BROKE, AND THE RING COVER AND RING BAIL WERE MISSING. NO ISSUES WERE FOUND WITH THE DEVICE SHUTTING OFF TOO SOON AFTER THE BATTERY WAS REMOVED.

    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. FURTHER INVESTIGATION BY THE BIOMEDICAL ENGINEERING DEPARTMENT SHOWED A CRACK IN THE TOP LEFT SIDE OF THE CASE, A HOLE IN THE BOTTOM IN THE PLASTIC IN THE JOIN OF THE TOP AND BOTTOM CASES, AND IT APPEARED THE BOTTOM SCREW WAS NOT HOLDING, AS THE INTERNAL POST WAS SNAPPED OFF THE CASE. THE DEVICE APPEARED TO HAVE BEEN DROPPED AT SOME STAGE. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS ON A PATIENT WHEN THE LOW BATTERY INDICATOR CAME ON. DURING THE BATTERY CHANGE, THE BACK-UP MECHANISM DID NOT "KICK IN." THE PATIENT STOPPED BEING PACED AND WENT INTO ASYSTOLE. TWO BATTERIES WERE INSERTED INTO THE DEVICE, BUT IT DID NOT WORK, SO THE DEVICE WAS CHANGED. INVESTIGATION BY ICU (INTENSIVE CARE UNIT) STAFF AFTER THE INCIDENT SAID THE DEVICE SEEMED TO BE WORKING. THE BATTERY DRAWER WAS FOUND TO BE "A BIT STIFF" WHEN CHECKED IN THE BIOMEDICAL ENGINEERING DEPARTMENT. THE RUN TIME AFTER BATTERY REMOVAL WAS TESTED NUMEROUS TIMES UNDER VARIOUS SETTINGS, AND THE TIME VARIED BETWEEN APPROXIMATELY 13-16 SECONDS, AFTER THE LOW BATTERY INDICATOR ILLUMINATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS ON A PATIENT WHEN THE LOW BATTERY INDICATOR CAME ON. DURING THE BATTERY CHANGE, THE BACK-UP MECHANISM DID NOT "KICK IN." THE PATIENT STOPPED BEING PACED AND WENT INTO ASYSTOLE. TWO BATTERIES WERE INSERTED INTO THE DEVICE, BUT IT DID NOT WORK, SO THE DEVICE WAS CHANGED. INVESTIGATION BY ICU STAFF AFTER THE INCIDENT SAID THE DEVICE SEEMED TO BE WORKING. THE BATTERY DRAWER WAS FOUND TO BE "A BIT STIFF" WHEN CHECKED IN THE BIOMEDICAL ENGINEERING DEPARTMENT. THE RUN TIME AFTER BATTERY REMOVAL WAS TESTED NUMEROUS TIMES UNDER VARIOUS SETTINGS, AND THE TIME VARIED BETWEEN APPROXIMATELY 13-16 SECONDS, AFTER THE LOW BATTERY INDICATOR ILLUMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R