BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2053080 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00533
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 25, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(6) 2011, ATTEMPTING TO GET MFG DATE. (B)(4).

    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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. THE CONNECTOR WAS FOUND TO BE OUT OF SPECIFICATION. THE CONNECTOR PIN OUT DID NOT MATCH THE PIN OUT FROM A KNOWN GOOD CABLE CONNECTOR. CONTINUITY TESTS WERE COMPLETE, NO CONNECTIONS WERE SHORTED TOGETHER, AND NO INTERMITTENT OPENS WERE FOUND WHEN THE CABLE WAS BENT/MANIPULATED. VISUAL INSPECTION FOUND ADHESIVE ON THE CABLE IN TWO SPOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED AN "INVERSION IN THE CABLE." A NEW CABLE WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT OUTCOME WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED AN "INVERSION IN THE CABLE." A NEW CABLE WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU INSTRUMENT CABLE DTE MEDTRONIC, INC. 05328 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R