BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190903 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05885
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN UNDERDOSE WITH THE SYMPTOMS OF NAUSEA, SWEATING (DIAPHORESIS), SPASM AND WRETCHING HAD OCCURRED FOLLOWING A STEROID INJECTION ADMINISTERED BY AN ANESTHESIOLOGIST AT THE VERTEBRAL LEVEL WHERE THE CATHETER TIP WAS IMPLANTED. THERE WERE NO AUDIBLE ALARMS AND THE PUMP WAS NOT INTERROGATED AT THAT POINT. IT WAS LATER REPORTED ON (B)(6) 2011, THAT THE PT STATED EXPERIENCING WITHDRAWAL SYMPTOMS FOLLOWING A DAY AFTER PAIN MANAGEMENT INJECTION INTO THE LOWER BACK. ON (B)(6)2011, CATHETER DYE STUDY REVEALED EXTRAVASATIONS OF DYE IN THE VICINITY. A BREAK, TEAR, HOLE WAS STATED AS THE CAUSE. THE CATHETER WAS HENCE REVISED. PT RECOVERED WITHOUT SEQUELAE. THE DRUG DELIVERED VIA THE PUMP WAS NOT REPORTED.

    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 68 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8596, LOT # B005120N43| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT #B005594N53