BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864060 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11372
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER "MALFUNCTION." A CT MYELOGRAM WAS PERFORMED; HOWEVER, THE REPORTER WAS UNSURE IF THE RESULTS WERE NORMAL OR ABNORMAL. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS FOLLOWED BY OVERDOSE SYMPTOMS TWICE. SPECIFIC SYMPTOMS INVOLVED IN THE EVENT WERE HYPOTONIA AND SEVERE SPASTICITY. IT WAS STATED THAT THERE WAS AN UNKNOWN ISSUE WITH THE DISTAL SEGMENT OF THE CATHETER. A CATHETER DYE STUDY ON (B)(6) APPEARED NORMAL, BUT A CT DYE STUDY THE SAME DAY SHOWED NO SPREAD OF THE DYE. NORMAL ROTOR MOVEMENT WAS ALSO SEEN THAT DAY IN A PUMP ROTOR STUDY. IT WAS NOTED THAT THERE WERE MULTIPLE DOSE ADJUSTMENTS THROUGHOUT THE WITHDRAWAL AND OVERDOSE SYMPTOMS. A CATHETER REVISION WAS PERFORMED ON (B)(6) AND IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention