BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3841338 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01492
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N184831007, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PARTIAL POCKET FILL. ABOUT 20 MILLILITERS WERE PUSHED IN AND THEN 10 MILLILITERS WERE ABLE TO BE PULLED BACK. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DOSE OF THE MORPHINE WAS UNKNOWN. EXACT SYMPTOMS THE PATIENT WAS HAVING INCLUDED HIVES AND REDNESS AROUND THE PUMP SITE. THE CAUSE OF THE POCKET FILL WAS UNKNOWN AS WELL. IN TERMS OF HOW THE PATIENT WAS NOW DOING, THEY WERE NOTED TO BE STABLE BUT NOT RECEIVING THERAPY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED VIA MANUFACTURER REPORT # 3004209178-2014-09921. ADDITIONAL INFORMATION RECEIVED R EGARDING THIS EVENT WILL BE REPORTED VIA THIS MANUFACTURER REPORT. IT WAS REPORTED (ON (B)(6) 2014) THAT THERE WAS A POCKET FILL WHICH REQUIRED THE PATIENT BE MONITORED IN THE OFFICE. IT WAS NOTED THAT THE POCKET SITE WAS ASPIRATED AND THE PHYSICIAN INJECTED NORMAL SALINE TO DILUTE THE DRUG IN THE SUBCUTANEOUS TISSUE. THE PATIENT WAS DESCRIBED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT, HOWEVER THE PATIENT DID EXPERIENCED AN ALLERGIC REACTION AROUND THE POCKET SITE. THE PUMP WAS INFUSING MORPHINE. IT WAS REPORTED TWO WEEKS LATER THAT THE CAUSE OF THE POCKET FILL WAS UNKNOWN. THE PATIENT REPORTEDLY EXPERIENCED ITCHING AND REDNESS AT THE POCKET SITE. AT THAT TIME THE PATIENT WAS DESCRIBED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318756 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR