BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920061 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10170
    Event Type
    Injury
    Date Received
    December 3, 2010
    Report Date
    November 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AIR ON THE FLUID IN BRAIN.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED DUE TO HEADACHE (DATE THIS OCCURRED NOT REPORTED). THE EMERGENCY DEPARTMENT PHYSICIAN INDICATED THE PT HAD "AIR ON THE FLUID IN HER BRAIN" AND THIS WAS RELATED TO THE PUMP. THE PT WAS TOLD BY THE NEUROSURGEON THAT IT WAS NOT RELATED TO THE PUMP. ADDITIONALLY, THE PUMP REFILL NURSE DID NOT ASPIRATE THE OLD DRUG FROM THE PUMP BEFORE REFILLING. AT ONE POINT (SPECIFIC DATE NOT REPORTED) THE PT EXPERIENCED FLUID NEAR THE PUMP AND IT WAS DRAINED. ON (B)(6) 2010, THE PT EXPERIENCED HEADACHE. THE PT WAS CONSIDERING ADDITIONAL TREATMENT OPTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N245093001| EXPLANTED: