BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2140938 · Received June 21, 2011

    Report

    Report Number
    3007566237-2011-04647
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH NO SYMPTOMS AND THEN THERE WAS A CONCERN REGARDING THE PUMP RUNNING FAST. LATER, THE PATIENT EXPERIENCED SYMPTOMS OF NUMBNESS AROUND THE MOUTH AND EDEMA AND REPORTED TO ER. THE PUMP WAS FILLED WITH 20CC (CAPACITY 40CC) AND THE READING WAS CORRECT WHEN REFILLED THE NEXT DAY. THE PUMP READ 3.4CC AND CONTAINED 3.4CC. THE PATIENT WAS RECEIVING THE DOSAGE THAT WAS SCHEDULED. THERE WAS SOME UNCERTAINTY AROUND THE AMOUNT INJECTED INTO THE PUMP AT THE LAST REFILL ON (B)(6) 2011. ON (B)(6) 2011, IT WAS REPORTED THAT THE LOGS SHOWED A MOTOR STALL ON (B)(6) 2011 WITH NO RECOVERY. THE PATIENT HAD SYMPTOMS OF NAUSEA AND VOMITING DURING THE REFILL CYCLE. THE PUMP WAS REPLACED ON (B)(6) 2011 AND THERAPY WAS RESUMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Required Intervention EXPLANTED:| CATHETER: MODEL 8731, LOT# N002703627| IMPLANTED: