BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2083031 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03256
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SEROMA. IT WAS ALSO REPORTED THAT DURING A PUMP REFILL, THE PT HAD A POCKET FILL. THE PT'S SYMPTOMS WERE REPORTEDLY OVER A PUMP LOCATION. AT THE TIME THAT THE EVENT WAS REPORTED, THE PT WAS AT A CLINIC. THE PT HAD NOT HAD ANY OVER DOSE SYMPTOMS OR ANY OTHER THERAPY PROBLEMS. THE DRUG IN THE PUMP WAS NOT KNOWN AT THE TIME THE EVENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 13 YR Other CATHETER: MODEL 8709, LOT# J11535R37| IMPLANTED:| EXPLANTED: