BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1870687 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07896
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT "NUMEROUS ORGANS WERE DAMAGED, PARALYZED" DUE TO HER PUMP. THE PT'S BLADDER WAS PARALYZED AND SHE HAD HER UTERUS REMOVED. THE PT ALSO REPORTED THAT SHE DEVELOPED AN INFECTION FOLLOWING A GALLBLADDER SURGERY. THE PT INTENDED TO HAVE HER PUMP EXPLANTED AFTER THE INFECTION WAS RESOLVED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N072590011| EXPLANTED:| IMPLANTED: