BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4220736 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20831
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A CATHETER AND PUMP REPLACEMENT, THE PATIENT WAS HOSPITALIZED FOR 2 NIGHTS AND REQUIRED A DOSE INCREASE. THE PATIENT HAD EVIDENCE OF WITHDRAWAL SIGNS AND SYMPTOMS WHEN STARTED ON POST-OPERATIVE DOSE OF 100MCG/DAY. AS OF 2014 (B)(6), THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN 700MCG/DAY AND CLONIDINE 254MCG/DAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. PLEASE SEE MANUFACTURER REPORT # 3004209178-2014-20619 FOR INFORMATION REGARDING THE CATHETER AND PUMP REPLACEMENT.

    Description of Event or Problem · 1

    PER THE PHYSICIAN, THE REASON FOR THE WITHDRAWAL WAS BECAUSE THEY STARTED THE PATIENT AT A LOW DOSE AFTER THE REVISION AND THEN TITRATED HIM BACK UP. THE PATIENT WAS BACK TO BASELINE AND HAD NO FURTHER SYMPTOMS OF WITHDRAWAL OR AFTER EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700941 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization