BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-STANDARD SYNERG DETECTION CIRCUIT

    MDR report key: 791140 · Received November 22, 2006

    Report

    Report Number
    6000078-2006-00559
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    October 26, 2006
    Report Date
    October 26, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    HCG
    PMA / PMN Number
    k991134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K001083. NO CONSEQUENCE OR IMPACT TO PATIENT CHOSEN BECAUSE THE PRODUCT PROBLEM WAS NOTICED AT PREPARATION. THE DEVICE IN QUESTION HAS BEEN RETURNED AND IS CURRENTLY IN PROCESS OF EVALUATION. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONFIRM THE USER'S COMPLAINT AND CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 10/26/2006 A PRODUCT PROBLEM OCCURRING DURING DEVICE PREPARATION OF A COILING PROCEDURE. IT WAS REPORTED THAT "THE COIL (DEVICE IN QUESTION) WAS NOT INSIDE THE PATIENT. DURING TESTING OF THE COIL, THE PHYSICIAN FOUND OUT THAT THE COIL WAS NOT CONNECTED WITH THE PUSHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-STANDARD SYNERG DETECTION CIRCUIT 84 HCG-DETACHABLE COIL HCG BOSTON SCIENTIFIC CORK LTD. 340820-4 6453644

    Patients

    Seq Age Sex Outcome Treatment
    1 *