BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063725 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02818
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TWO DAYS AFTER IMPLANT, THE PT WAS HAVING SYMPTOMS THAT LOOKED SIMILAR TO WITHDRAWAL; THE PT HAD INCREASED SPASTICITY. THE PHYSICIAN CHECKED THE CATHETER UNDER FLUORO AND GAVE THE PT A SINGLE BOLUS OF 100 MCG OF INTRATHECAL BACLOFEN TO SEE IF IT WOULD HELP. THEY SAW VERY MILD IMPROVEMENT. THE PUMP DOSE WAS INCREASED 9% TO 1846.6 MCG/ML; THE CONCENTRATION WAS 2500 MCG/ML OF COMPOUNDED BACLOFEN. THE PT'S TONE IMPROVED, BUT OTHER SYMPTOMS DID NOT. ON (B)(6) 2011, THE PT WAS TAKEN TO THE HOSP WHERE SHE WAS ADMITTED FOR CONFIRMED ASPIRATION PNEUMONIA WITH SYMPTOMS THAT LOOKED VERY SIMILAR TO WITHDRAWAL. ON (B)(6) 2011, PUMP INTERROGATION SHOWED NO ALARMS AND THE CALCULATED FLOW RATE WITH PUMP VOLUME WAS CORRECT. NO DOSE ADJUSTMENT OCCURRED AT THAT TIME. THEY PLANNED TO CONTINUE TO MONITOR "BOTH ASPECTS". THE PT WAS REPORTED TO BE RECOVERING FROM THE PNEUMONIA.

    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 27 YR Hospitalization LOT# NGV413506H| IMPLANTED:| CATHETER: MODEL 8578, LOT# N126907| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740| EXPLANTED:| EXPLANTED: