BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190371 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05732
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PAST TWO REFILLS, THE HEALTH CARE PROVIDER WAS ONLY ABLE TO PULL OUT HALF OF THE MEDICATION. THE PT USED TO HAVE REFILLS EVERY SIX WEEKS, BUT RECENTLY THEY HAD BEEN EVERY TWENTY DAYS. THE PT'S DOSAGE IS INCREASED AT EACH REFILL BECAUSE OF PAIN. THE PT HAD A CHANGE IN THERAPEUTIC EFFECT AND HAS HAD A FEW FALLS. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION 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 56 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N137764005