BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5049570 · Received September 2, 2015

    Report

    Report Number
    3004209178-2015-17130
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N100014, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE NOTED AS NON-MALIGNANT PAIN AND POST-LAMINECTOMY PAIN. INITIAL INTERROGATION OF THE PUMP REVEALED THAT A MOTOR STALL OCCURRED WITH NO RECOVERY HAD OCCURRED. THE PATIENT HAD AN MRI ON (B)(6) 2015 BETWEEN 8:00-9:00 AM AND IT WAS NOW 14:46 AND THE MOTOR STALL HAD NOT RECOVERED. THERE WERE NO PATIENT SYMPTOMS. THE PATIENT WAS CURRENTLY NOT RECEIVING THERAPY FROM THE INFUSION SYSTEM. INTERVENTIONS AND OUTCOME NOT REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582365 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR