BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191497 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10947
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN OVERDOSE, WAS COMATOSE AND UNRESPONSIVE. THE PATIENT WAS GIVEN NARCAN AND IMMEDIATELY RESPONDED. THE MANAGING HOSPITAL PHYSICIAN WANTED THE PUMP STOPPED. PER THE PATIENT FAMILY, THERE HAD NOT BEEN A REFILL OR REPROGRAMMING DONE RECENTLY, AND THE PT DIDN'T TAKE ANYTHING ELSE. THE PUMP WAS USED TO DELIVER HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291314 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R