BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4131742 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18055
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/DEVICE EVALUATION SUMMARY: THE ANCHOR DEPLOYMENT TOOL WAS RECEIVED FOR ANALYSIS. THE HYPOTUBE WAS SEPARATE FROM THE ANCHOR DEPLOYMENT TOOL BASE AS RECEIVED. ANALYSIS FOUND THAT THE HANDLE MOMENTARILY SLIPPED FROM THE BASE OF THE ANCHOR DEPLOYMENT TOOL. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN, SERIAL# UNKNOWN, PRODUCT TYPE: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ANCHOR DEPLOYMENT TOOL CAME APART WHEN DEPLOYING CAUSING THE ANCHOR TO PULL THE CATHETER BACK AND WAS NOT IN THE LOCATION THE CLINICIAN DESIRED. HOWEVER; NO TROUBLESHOOTING, INTERVENTION OR OTHER ACTIONS WERE TAKEN TO RESOLVE THE CATHETER PULLING BACK OUT OF LOCATION BECAUSE IT WAS NOT NECESSARY. IT WAS NOTED NO ACTIONS WERE REQUIRED AS A RESULT OF THE EVENT. THE CAUSE OF THE ISSUE WAS UNDETERMINED. THE DEPLOYMENT TOOL WOULD BE SENT BACK FOR ANALYSIS. IT WAS FURTHER REPORTED THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE- NO INJURY.¿ THE PATIENT WAS DOING WELL. THE PUMP WAS BEING USED TO DELIVER MORPHINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER AND AN UNKNOWN NEUROMODULATION DEVICE WERE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612655 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR