BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3072931 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06755
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC. SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A QUARTER-COIN SIZED BLUE AND RED DISCOLORATION ON THE PATIENT'S ABDOMINAL SKIN SUPERIOR TO THE PUMP. THERE WAS ALSO TISSUE BREAKDOWN INSIDE THE PUMP POCKET OBSERVED INTRA-OPERATIVELY. THE NEUROSURGEON FELT THAT THE WHEELCHAIR WAS POSSIBLY CAUSING MECHANICAL FRICTION. THE PUMP AND CATHETER WERE EXPLANTED. PROPHYLACTIC ANCEF WAS GIVEN TO THE PATIENT INTRAVENOUSLY PRIOR TO THE SURGERY, AND AEROBIC AND ANAEROBIC CULTURES WERE TAKEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A 23 HOUR STAY TO OBSERVE FOR SIGNS/SYMPTOMS OF WITHDRAWAL, AND WAS STARTED ON A REGIMEN OF ORAL BACLOFEN. THE PATIENT STATUS WAS "ALIVE" NO INJURY/NO ADVERSE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175099 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Hospitalization| R