BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3780963 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08294
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 2014
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED DURING A PUMP REFILL ON (B)(6) 2014. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 3.8ML AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 7ML. SHORTLY AFTER, WHILE STILL IN THE OFFICE, THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS OF SOMNOLENCE, LETHARGY, DIZZINESS AND SLURRED/SLOW SPEECH. IT WAS NOTED THAT THE RESERVOIR WAS CHECKED AFTER THE PATIENT STARTED TO EXHIBIT SYMPTOMS. THE NURSE MADE SURE THAT SHE GOT BACK THE 40ML THAT SHE JUST PUT IN THE PUMP, AND SHE DID GET BACK 40ML. IT WAS BELIEVED THAT THE PATIENT WAS MONITORED FOR A PERIOD OF TIME BEFORE BEING DISCHARGED. A DYE STUDY WAS PERFORMED ON (B)(6) 2014 AND THE MANAGING PHYSICIAN HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE. AT THIS TIME, THE PATIENT SEEMED NORMAL WITHOUT COMPLAINTS. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND CLONIDINE. IT WAS LATER REPORTED THAT THE LOCATION OF THE CATHETER ISSUE HAD NOT BEEN DETERMINED. SINCE THE PHYSICIAN WAS UNABLE TO ASPIRATE DURING THE DYE STUDY, NO DYE WAS INJECTED. AS OF (B)(6) 2014, NO FURTHER ACTIONS HAD BEEN TAKEN. ON (B)(6) 2014, THE PATIENT SEEMED TO BE DOING FINE WITH NO OUTWARD SIGNS OR SYMPTOMS. THE REPORTER DID NOT KNOW WHAT THE MANAGING PHYSICIAN WAS PLANNING ON DOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260088 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other