BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242742 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12163
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR DOCTOR REFILLED THE PUMP ON (B)(6) 2013 AND ¿IT WAS COMPLETELY DRY¿. THEY STATED THAT, AFTER THE REFILL, ¿IT MADE THEM SO SICK THEY COULD NOT EVEN DRIVE HOME¿, AND IT LASTED FOR A COUPLE DAYS. THEY NOTED THEY HAD BEEN THROUGH THAT BEFORE, ¿WHEN THEY GO IN FOR PAIN MEDICINE AND THEY PUT IT THROUGH YOUR VEIN OR SOMETHING LIKE THAT¿; THEY STATED ¿THEY FELT THAT WAS WHAT HAPPENED TO THEM LIKE A HUNDRED TIMES WORSE¿. SHE STATED THAT IT FELT LIKE THEIR HEALTHCARE PROVIDER PUT SOMETHING IN THEIR VEIN. THE PATIENT STATED THAT THEY DID NOT KNOW WHY THEIR PUMP WAS ¿SO DRY¿ AND THEY DID NOT GET ALERTED FOR IT BECAUSE ¿THEY SUPPOSEDLY HAD BEEPED¿. THEY STATED THEIR HCP ¿DID NOT HAVE A LICK COME OUT OF THAT SYRINGE¿. THEY FURTHER CLARIFIED THAT THEY HAD BEEN SCHEDULED FOR A REFILL ON (B)(6) 2013 AND THEY WENT TO THEIR REFILL ON (B)(6) 2013; THAT THEY DID NOT MISS A SESSION OR ANYTHING. THEY CONFIRMED THEY NEVER HEARD AN ALARM. THE PATIENT¿S MEDICATION AND DOSAGE WERE NOT CHANGED AT THAT REFILL. THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344170 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other