BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2172588 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05608
    Event Type
    Injury
    Date Received
    July 20, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED HER PUMP REFILL DATE WAS DUE ON (B)(6) 2011. SINCE SHE HAD RELOCATED SHE WAS YET TO FIND A HCP. LATER, ON (B)(6) 2011, HCP REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL, REASON UNK. PT STATUS UNK. A F/U REPORT WILL BE SENT 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8591, LOT# C35349| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N224101011