BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190375 · Received July 25, 2011

    Report

    Report Number
    3007566237-2011-05742
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DID NOT HAVE THERAPEUTIC EFFECT. THE PT EXPERIENCED AN INCREASE IN PAIN. THE PT'S PAIN IS ON HIS SIDE. THE PT REPORTED THAT THEY HAD NEVER HAD GOOD RELIEF WITH THE DEVICE. THE PT HAD BEEN GIVEN HYDROCODONE BY HIS CANCER SPECIALIST. THE PT HAD NOT HAD A REFILL FOR OVER A YEAR. AN ALARM WAS SOUNDING. IT WAS LATER REPORTED THAT THE PT'S PUMP HAD BEEN EMPTY FOR BETWEEN SIX AND TWELVE MONTHS. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. 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 MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention CATHETER: MODEL 8709, LOT# J11755R26.| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11755R26| EXPLANTED: