BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1910626 · Received November 19, 2010

    Report

    Report Number
    3007566237-2010-09820
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SEEN IN THE EMERGENCY ROOM ON (B)(6) 2010 FOLLOWING A FALL THE PREVIOUS DAY. THE PT HAD BEEN VOMITING. A CT SCAN WAS PERFORMED AS THE PT BELIEVED HER PUMP WASN'T WORKING. A CATHETER PROBLEM WAS DETECTED; SPECIFIC DETAILS WERE NOT PROVIDED. ACCORDING TO THE REPORTER, THE CATHETER WAS REPLACED ON (B)(6) 2010. THE PUMP DOSE WAS INCREASED THE FOLLOWING DAY. THE PT "RECOVERED FROM THE REVISION WITHOUT ANY PROBLEMS". THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PTM, LOT# UNK| CATHETER: MODEL 8709SC, LOT# N186302030