BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050177 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05855
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FELL STRAIGHT FORWARD ONTO THEIR STOMACH, AND HIT HERSELF "PRETTY HARD." SHE PRESENTED AT THE EMERGENCY ROOM (ER) WITH SLURRED SPEECH AND WEAKNESS. THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO INTERROGATE THE PUMP, BOTH WITH THE MAGNET AND WITHOUT, "EITHER WAY NOTHING COMES OUT," "IT JUST DOESN'T REGISTER ANYTHING," AND "NOTHING GOES OUT." THE PATIENT WAS DUE FOR REFILL (B)(6) 2013, "SO POSSIBLY IT'S EMPTY." IT WAS NOTED THAT NO ALARMS WERE HEARD. THE DEVICE WAS USED TO INFUSE DILAUDID AND MARCAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149669 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization