BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143037 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04685
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 3004209178-2011-04251: [IN (B)(6) 2011, THE PT WAS EXPERIENCING INCREASED DIFFICULTY WALKING AND DIFFICULTY STANDING; THE SYMPTOMS WERE SIMILAR TO THOSE PRIOR TO THE PUMP BEING IMPLANTED. AT REFILLS, "ALL THE AMOUNT WAS ACCOUNTED FOR." THE PUMP WAS REPLACED. AS OF (B)(6) 2011, THE PT WAS IN THE HOSPITAL FOLLOWING THE PUMP REPLACEMENT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.] NEW INFORMATION FOR EVENT: THE PT ALSO EXPERIENCED INCREASED HYPERTONIA. IT WAS DETERMINED THAT THE DISTAL END (SPINAL SEGMENT) OF THE CATHETER WAS CONCLUDED. THE CATHETER WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    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 65 YR Hospitalization| R EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N276941002| IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| LOT# NGV446416H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709 LOT# J55543R18