BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1844583 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07226
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6), 2010 THAT THE CLINICIAN PROGRAMMER WAS FROZEN OR NOT RESPONDING. FOLLOWING REPOWERING THE CLINICIAN PROGRAMMER BY TURNING OFF AND ON, THE PROGRAMMER WAS WORKING. THE PUMP MIGHT HAVE BEEN IN STOP MODE. (B)(6), 2010, THE HCP PERFORMED A CATHETER DYE STUDY. THEY ASPIRATED THROUGH THE CATHETER ACCESS PORT AND PULLED FLUID BACK. THEY INJECTED THE DYE AND THOUGHT THEY SAW IT POOL AROUND THE PUMP. THEY DID NOT SEE ANY IN THE CATHETER OR CEREBROSPINAL FLUID. THE FOLLOWING DAY, THE HCP WAS GOING TO TRY THE DYE STUDY AGAIN BUT THEY WERE NOT ABLE TO ASPIRATE. (B)(6), 2010, THE PT WENT IN FOR A CATHETER REVISION. THE SUTURELESS CONNECTION WAS INTACT. A NEW CATHETER WAS PUT IN. PT WAS IN RECOVERY. LIORESAL WAS IN THE PUMP.

    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 34 YR Required Intervention PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| CATHETER: MODEL 8575, LOT# N076422| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N235480005| EXPLANTED:| IMPLANTED: