BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093631 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03457
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PT WOKE UP TWO WEEKS AGO, THE PT WAS UNABLE TO MOVE AND HAD DIFFICULTY BREATHING. THE PT HAD VISITED THE CLINIC THREE TIMES DURING THE PAST WEEK. TO DETERMINE THE ISSUE, MRIS AND BLOOD TESTS WERE PERFORMED. THE BLOOD TEST INDICATED THAT METHADONE WAS PRESENT. IT WAS FURTHER REPORTED THAT THE PT RECEIVED A PILL FROM HER NEIGHBOR SIX DAYS PRIOR TO THE BLOOD TEST. THE NAME OF THE PILL WAS NOT KNOWN. THE PT HAD BEEN SCHEDULED FOR A DYE STUDY, BUT DID NOT GO TO HER SCHEDULED APPOINTMENT. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other EXPLANTED:| CATHETER: MODEL 8709, LOT # N099049001| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N137883015| IMPLANTED: