BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190753 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05799
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP REFILL ON (B)(6), 2011 IN THE HEALTH CARE PROVIDER'S OFFICE. THE PROCEDURE REPORTEDLY "WENT BADLY" AND THE PUMP POCKET WAS FILLED "WITH PART OF HIS DOSE." LATER THAT DAY, THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM (ER) FOR VOMITING AND LETHARGY. IN THE EMERGENCY ROOM, HE HAD A RESPIRATORY ARREST REQUIRING INTUBATION. HE STABILIZED AND WAS SENT TO A CHILDREN'S HOSPITAL FOR CARE. HE WAS SAFELY EXTUBATED THE NEXT AM AND HAD DONE WELL SINCE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N194489005| IMPLANTED: