BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230542 · Received August 12, 2011

    Report

    Report Number
    3007566237-2011-06298
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN OVERDOSE. THE PT WAS INTUBATED. THE CAUSE OF THE EVENT WAS AN ACCIDENTAL OVERDOSE. THE PT HAD A SERIOUS INJURY AND THEN RECOVERED WITHOUT SEQUELAE. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE HYDROMORPHONE AND BUPIVICAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 883720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization CATHETER: MODEL 8709, LOT# J13101R23| EXPLANTED:| IMPLANTED: