BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1823435 · Received August 25, 2010

    Report

    Report Number
    3007566237-2010-06449
    Event Type
    Injury
    Date Received
    August 25, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 AN OVERDOSE FOLLOWING A PUMP REFILL HAD OCCURRED. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF THE PUMP BEING OVERFILLED. THE PT WAS SENT TO THE ER AND REMAINED IN THE ICU FOR ONE WEEK. THE PT EXPERIENCED COGNITIVE CHANGES, DROWSINESS, AND RESPIRATORY DEPRESSION. THE DEVICE IS NOT PLANNED TO BE EXPLANTED/REPLACED. IT WAS NOTED AS BEING "UNK" IF THE ISSUE WAS ATTRIBUTED TO ANY COMPONENTS OF THE DEVICE SYSTEM. A CT SCAN INDICATED NORMAL RESULTS, AND THAT THERE WAS NO FLUID IN THE DEVICE POCKET SITE. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY, AND ADJUSTED TO ITS NORMAL SETTING. THE PT HAD LATER RECOVERED WITHOUT SEQUELA. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    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 NA Female Hospitalization| R CATHETER: MODEL 8731, LOT # N001472212.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # N001472212| EXPLANTED:| IMPLANTED: