BEUDAMED
    FDA Adverse Event Other Summary report: N

    MATRIX2 SOFT 360 SR COIL

    MDR report key: 1282740 · Received January 7, 2009

    Report

    Report Number
    2939204-2009-00049
    Event Type
    Other
    Date Received
    January 7, 2009
    Date of Event
    December 4, 2008
    Report Date
    December 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: OTHER, FOR NO ALLEGATION OF PRODUCT NON-CONFORMANCE OR MALFUNCTION CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A FEVER ("NEAR 39 DEGREES C") TWO DAYS AFTER THE SUCCESSFUL COIL EMBOLIZATION OF THE BASILAR TIP ANEURYSM. THE FEVER CONTINUED FOR FIVE DAYS. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE COILS USED (SUBJECT DEVICE) MIGHT BE RELATED TO THE EVENT. IT WAS ALSO REPORTED THAT THE PHYSICIAN FELT THAT THE FEVER WAS UNRELATED TO BACTERIAL INFECTION DUE TO NO C-REACTIVE PROTEIN (CRP) INCREASES. THE PT HAS A HISTORY OF AMYGDALITIS. THE PT WAS REPORTED TO BE IN "GOOD" CONDITION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RETRIEVE FURTHER INFORMATION. NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 SOFT 360 SR COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP. 490615-SR 11924290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HYPERFORM OCCLUSION BALLOON (EV3)| EDC10 EXTRA SOFT (MANUFACTURER UNK)| 3 MATRIX2 COILS (BOSTON SCIENTIFIC)| TRANSEND| EXCELSIOR SL 10| SELESITE UTIPAQ (MICRUS)| 3 MICROSPHERE COILS (MANUFACTURER UNK)