BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872614 · Received October 12, 2010

    Report

    Report Number
    3007566237-2010-07886
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    December 26, 2009
    Report Date
    April 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT EXPERIENCED VOMITING "SINCE (B)(6), 2009" AND STATED, SHE FELT "LIKE THE PUMP WAS MALFUNCTIONING." THE PT STATED, SHE FELT SIMILAR TO HOW SHE FELT WHEN THE PUMP BATTERY ON A PREVIOUS DEVICE BECAME DEPLETED. THE PT DID NOT REPORT ANY OTHER SYMPTOMS AND STATED THAT NO ALARMS WERE COMING FROM THE DEVICE. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE SULFATE. REFERENCE MFR REPORT #6000030-2005-01144. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# J0040000R| EXPLANTED: