BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2141129 · Received June 22, 2011

    Report

    Report Number
    3007566237-2011-04677
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 THAT THE PATIENT WAS FOUND UNRESPONSIVE AND TAKEN TO THE EMERGENCY ROOM. THE PATIENT ALSO HAD RESPIRATORY DISTRESS. AN OVERDOSE WAS SUSPECTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WAS A MOTOR STALL AND RECOVERY ALARM AND WHETHER THIS WAS FOLLOWING AN MRI WAS NOT CONFIRMED. NO VOLUME DISCREPANCY WAS NOTED. THE CORRECT CONCENTRATION, DRUG AND DOSE WERE PROGRAMMED. THE DRUG REPORTED WAS DILAUDID. THE PUMP WAS LAST REFILLED ON (B)(6) 2011. IT WAS ALSO REPORTED THAT THE PATIENT DOES TAKE ORAL PAIN MEDICATIONS. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L75455