BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2160670 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05182
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS IMPLANTED ON (B)(6) 2011 IN THE ABDOMEN. ON (B)(6) 2011, IT WAS REPORTED THERE WAS A POSSIBLE INFECTION. THE PT HAD A FEVER, A RASH, WAS "TIGHT," AND WAS "NOT HERSELF." THE PT EXPERIENCED WITHDRAWAL SYMPTOMS. A CULTURE WAS OBTAINED IN THE HCP OFFICE; THE RESULTS WERE UNK BY THE REPORTER. THE PT WAS STARTED ON AN ANTIBIOTIC. AS OF (B)(6) 2011, THE PT WAS "FINE." THE HCP TRIED TO ASPIRATE THE CATHETER BUT WAS UNABLE TO ACCESS THE CATHETER; THE HCP DID NOT HAVE THE RIGHT CAP KIT. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention CATHETER: MODEL 8709, LOT# J11164R51| IMPLANTED:| EXPLANTED: