BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1863386 · Received October 9, 2010

    Report

    Report Number
    2183613-2010-00278
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 19, 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
    MN, US
    Reporter Occupation
    NURSE

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (ALERT DATE) CORRECTED. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ELECTRICAL ANOMALIES WERE FOUND. THE RING AND SIDE BAIL COVERS WERE ALSO FOUND TO BE BROKE, THE LEAD FLEX COVER WAS CORRODED, AND THE KEYBOARD WAS SCRATCHED. THESE VISUAL ANOMALIES WOULD NOT HAVE CAUSED THE REPORTED BEHAVIOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TRANSFERRED TO THE EP LAB FOR PERMANENT PACEMAKER IMPLANT. A TEMPORARY PACEMAKER WAS IN PLACE FROM SURGERY ON (B)(6)2010. WHILE PREPPING THE PATIENT, THE EPG (EXTERNAL PULSE GENERATOR) SHUT OFF. THE PACER DEPENDENT PATIENT BRIEFLY LOST CONSCIOUSNESS, WHILE A NEW DEVICE WAS RETRIEVED AND ATTACHED. THERE WAS IMMEDIATE RESPONSIVENESS WITH THE NEW DEVICE AND NO DETRIMENT TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT WHEN THE DEVICE HAD BEEN TURNED BACK ON, IT IMMEDIATELY SHUT OFF. A BAD BATTERY WAS SUSPECTED. TESTING WAS REQUESTED BECAUSE THE PROBLEM COULDN'T BE IDENTIFIED. IT WAS NOTED THAT THE LOCK KEY WAS CHECKED AND FOUND TO BE ON. THE DEVICE SHOULD NOT HAVE BEEN BUMPED OR SHUT OFF ACCIDENTALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TRANSFERRED TO THE EP LAB FOR A PERMANENT PACEMAKER IMPLANT. A TEMPORARY PACEMAKER WAS IN PLACE FROM SURGERY ON (B)(6) 2010. WHILE PREPPING THE PATIENT, THE EPG (EXTERNAL PULSE GENERATOR) SHUT OFF. THE PACER DEPENDENT PATIENT BRIEFLY LOST CONSCIOUSNESS, WHILE A NEW DEVICE WAS RETRIEVED AND ATTACHED. THERE WAS IMMEDIATE RESPONSIVENESS WITH THE NEW DEVICE AND NO DETRIMENT TO THE PATIENT. IT WAS ALSO REPORTED THAT WHEN THE DEVICE HAD BEEN TURNED BACK ON, IT IMMEDIATELY SHUT OFF. A BAD BATTERY WAS SUSPECTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. TESTING WAS REQUESTED BECAUSE THE PROBLEM COULDN'T BE IDENTIFIED. IT WAS NOTED THAT THE LOCK KEY WAS CHECKED AND FOUND TO BE ON. THE DEVICE SHOULD NOT HAVE BEEN BUMPED OR SHUT OFF ACCIDENTALLY.

    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