BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2822822 · Received November 7, 2012

    Report

    Report Number
    2954740-2012-00772
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BASED ON ADDITIONAL INFORMATION, THERE WAS NO EVENT OR PRODUCT MALFUNCTION ASSOCIATED WITH THE DEVICE, AND THEREFORE DOES NOT MEET THE CRITERIA FOR REPORTING. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE INDICATED THAT EIGHT WEEKS POST ANEURYSM COILING PROCEDURE USING MICRUS COILS, THE PATIENT WAS PRESENTED TO THE HOSPITAL. THE PATIENT WAS EXTREMELY UNWELL, SUFFERING FROM MULTIPLE AGGRESSIVE SEIZURES. THE MDR SCAN SHOWED SUBCORTICAL SWELLING WITH BILATERAL WHITE MATTER INVOLVEMENT. INITIALLY IT WAS ASSUMED THAT HER SYMPTOMS COULD POSSIBLY BE RELATED TO HER PREVIOUS COILING PROCEDURE AND SHE MAY HAVE ADEM. HOWEVER SINCE THEN, THE MEDICAL TEAM AND NEUROLOGISTS ARE CONVINCED THAT IT IS CO-INCIDENTAL AND THAT THE IMPLANTATION OF MICRUS COILS AND THE PATIENTS SYMPTOMS ARE COMPLETELY UNRELATED. SINCE THEN, THE PATIENT HAS BEEN PROGRESSIVELY IMPROVING. UNFORTUNATELY THE PATIENT DOES NOT HAVE A DEFINITE DIAGNOSIS AND THE PHYSICIAN COULD NOT PREDICT THE EXACT CAUSE OF ILLNESS. MULTIPLE SCLEROSIS HAS NOT BEEN RULED OUT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT, AN INQUIRY EMAIL FROM A NEUROLOGIST IN (B)(6) INQUIRING IF THERE ARE ANY REPORTS FROM MICRUS BARE PLATINUM COILS CAUSING ADEM (ACUTE DISSEMINATED ENXCEPHALOMYELITIS). A PATIENT HAD A COILING PROCEDURE WITH MICRUSPHERE AND DELTAPAQ BEING PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1