BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCROMED EL

    MDR report key: 656523 · Received December 22, 2005

    Report

    Report Number
    6000030-2005-02004
    Event Type
    Other
    Date Received
    December 22, 2005
    Date of Event
    December 6, 2005
    Report Date
    December 19, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED THE PUMP AND CATHETER WERE EXPLANTRED DUE TO AN INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S STOMACH KEPT ¿BREAKING OPEN¿ FROM THE PUMP; BUT THE PUMP WORKED. THE PATIENT STATED THAT THE SPASTICITY WAS ¿SO BAD, HER KNEES WERE UP AGAINST HER CHEST.¿ SHE LATER STATED THAT THE ¿THE PUMP WOULD TOTALLY LET IT GO.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCROMED EL PUMP LKK RICE CREEK MANUFACTURING 862710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O EXPLANTED: 2005.| CATHETER MODEL#8703W LOT#L58813 IMPLANTED: 1999