BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1981401 · Received February 1, 2011

    Report

    Report Number
    3007566237-2011-00771
    Event Type
    Injury
    Date Received
    February 1, 2011
    Report Date
    December 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ACTUAL RESIDUAL VOLUMES WERE GREATER THAN THE EXPECTED RESIDUAL VOLUMES. THE AMOUNTS VARIED, BUT HAS BEEN AS HIGH AS 8 ML OFF. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT AT THE TIME THAT THE PATIENT'S PUMP WAS REMOVED, THE PATIENT'S HEALTHCARE PROVIDER (HCP) COULD NOT FIND ANYTHING WRONG WITH THE PUMP. THE PATIENT'S PUMP WAS NOTED TO HAVE CONTAINED MORPHINE. THE CAUSE OF THE REPORTED EVENT WAS DUE TO THE PUMP, BUT THE ISSUE WAS UNKNOWN. THERE WAS NO PROBLEM WITH THE CATHETER, OR ISSUE WITH THE PROGRAMMING OR PUMP MEDICATION. THE PATIENT HAD EXPERIENCED AN INCREASE IN THE PAIN LEVEL PRIOR TO THE PUMP REPLACEMENT SURGERY. THE PATIENT WAS HOSPITALIZED FOR THE PUMP REPLACEMENT SURGERY. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PUMP WAS SUBSEQUENTLY REPLACED DUE TO VOLUME DISCREPANCIES AND RETURN OF SYMP TOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # N065666010