BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3031354 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04496
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N203997, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL (B)(6) 2012 AND WAS HOSPITALIZED OVERNIGHT. THE PHYSICIAN ADJUSTED THE DOSAGE, AND THE PATIENT WAS BETTER, BUT WAS NOT 100 PERCENT. THE PATIENT WAS SCARED AND WENT TO THE EMERGENCY ROOM FOR HELP ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WENT BACK TO THE HOSPITAL AS THEY WERE EXPERIENCING LEG TROUBLE AND WAS THERE OVERNIGHT AGAIN. THEN THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012, AND WAS "STRAIGHTENED OUT." FOLLOWING THE WITHDRAWAL, THE PATIENT'S FAMILY DOCTOR SENT HER TO A PAIN CENTER. THE PATIENT WAS DOING FINE. THE PUMP SYSTEM WAS BEING USED TO DELIVER SUFENTANIL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134143 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization