BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1980354 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00858
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INCREASED SPASTICITY. THE PATIENT WAS ADMITTED. IMAGING WAS CONDUCTED OF THE PUMP AND CATHETER. NO DISCONNECTIONS WERE SEEN. THE PUMP'S LOW RESERVOIR ALARM WAS ABOUT TO BEEP SO AN INPATIENT REFILL WAS PERFORMED. THERE WERE NO PUMP VOLUME DISCREPANCIES. NO DYE STUDY WAS PERFORMED. IT WAS FELT THAT THE PATIENT WAS STABLE AND WAS REFERRED TO HER MANAGING PHYSICIAN FOR FURTHER WORK-UP AND ANALYSIS. THE PUMP WAS ON A FLEX PATTERN DOSING SCHEDULE. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization EXPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG005140N| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N132467012| IMPLANTED: