BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920109 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10163
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING ADMITTED TO THE INTENSIVE CARE UNIT FOR MONITORING DUE TO SUSPECTED INTRATHECAL BACLOFEN WITHDRAWAL. THE HEALTHCARE PROFESSIONAL FELT THAT THE PATIENT'S CATHETER MAY BE COMPROMISED. THE PATIENT HAD BEEN SEEN IN CLINIC THE PREVIOUS DAY WITH SYMPTOMS OF INCREASED SPASMS, SPASTICITY, PAIN AND DIAPHORESIS. A BOLUS WAS PROGRAMMED THROUGH THE PUMP WITH NO IMPROVEMENT IN SYMPTOMS. THE PATIENT WAS ALSO GIVEN ORAL BACLOFEN WITH NO IMPROVEMENT. THE PUMP WAS REFILLED. THERE WERE NO PUMP VOLUME DISCREPANCIES. X-RAYS SHOWED THAT THE CATHETER WAS CONNECTED TO THE PUMP; AND APPEARED TO BE AT THE SAME LEVEL WHEN COMPARED TO IMPLANT FILMS. THE HEALTHCARE PROFESSIONAL WAS PLANNING TO STABILIZE THE PATIENT AND PROCEED WITH A CATHETER DYE STUDY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R CATHETER: MODEL #8709SC, LOT #N183159009.| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL #8709SC, LOT #N183159009| IMPLANTED: