BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920082 · Received December 3, 2010

    Report

    Report Number
    3007566237-2010-10166
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PUMP REFILL APPOINTMENT WAS MISSED. THE LOW RESERVOIR ALARM WAS (B)(6) 2010 AND THE PUMP WAS EMPTY (B)(6) 2010. ON (B)(6) 2010, TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING; THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PT EXPERIENCED WITHDRAWAL SYMPTOMS (SPECIFIC SYMPTOMS NOT REPORTED). THE PT HEARD THE ALARM TEST BUT DID NOT HEAR THE CRITICAL ALARM ON (B)(6) 2010. THE PUMP DELIVERED LIORESAL 500 MCG/ML AT 227 MCG/DAY. 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 MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11957R07