BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2073588 · Received April 27, 2011

    Report

    Report Number
    3007566237-2011-03125
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 12, 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).

    Description of Event or Problem · 1

    THE PUMP CONTAINED LIORESAL 500 MCG/ML. THE PUMP WAS FLIPPING AND THE CATHETER WAS "TWISTING." A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011. DURING SURGERY, THE HCP WAS ABLE TO ASPIRATE "A FEW DROPS" WHILE THE PUMP WAS ON THE BACK TABLE, BUT WAS UNABLE TO FILL THE PUMP RESERVOIR. FOUR DIFFERENT NEEDLES WERE USED TO TRY AND FILL THE PUMP WITHOUT SUCCESS. THE HCP DECIDED TO IMPLANT A DIFFERENT PUMP. THE INTERVENTION TO THE CATHETER WAS NOT REPORTED. PATIENT OUTCOME WAS NOT REPORTED. 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N265397015| IMPLANTED:| EXPLANTED: