BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4173796 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19730
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID; 8591-38, LOT# D10033, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS NOT EXPERIENCING HIS NORMAL PAIN RELIEF; HE HAD LESS THAN (B)(6) THERAPY RELIEF. A CATHETER CHECK WAS DONE UNDER FLUOROSCOPY AND NO CATHETER WAS SEEN IN THE INTRATHECAL SPACE. IT WAS DETERMINED THAT THE CATHETER HAD PULLED OUT AND WAS COILED UP BEHIND THE PUMP. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE OUTCOME OF THE EVENT AND THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2014-02477 [IT WAS REPORTED THAT A REVISION OCCURRED ON (B)(6)2014, AS THE CATHETER HAD COME OUT OF THE INTRATHECAL SPACE. ADDITIONAL DETAILS, INCLUDING PATIENT SYMPTOMS, CAUSE OF THE EVENT, TROUBLESHOOTING AND/OR DIAGNOSTICS PERFORMED AND PATIENT OUTCOME, WERE NOT REPORTED. ADDITIONAL FOLLOW-UP TO OBTAIN THIS INFORMATION IS BEING CONDUCTED. ] ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED IN MANUFACTURER REPORT # 3004209178-2014-19730

    Description of Event or Problem · 1

    THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE CATHETER MOVEMENT WAS NOT DETERMINED. THE ISSUE WAS RESOLVED FOLLOWING THE CATHETER REPLACEMENT. THE REMOVAL OF THE OLD CATHETER AND REPLACEMENT OF THE NEW CATHETER WAS A SUCCESS, AND PER THE REPORTER NO FURTHER ACTIONS HAD BEEN REQUESTED BY THE MANAGING/IMPLANTING HCP. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655544 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention