BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960945 · Received January 11, 2011

    Report

    Report Number
    3007566237-2011-00279
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 4, 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
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SPINAL SURGERY. FOLLOWING SURGERY, THE PATIENT EXPERIENCED SUDDEN-ONSET BACLOFEN WITHDRAWAL SYMPTOMS: LIP-BITING, TONGUE THRUSTING, UPPER EXTREMITY FLEXION/STIFFENING, DYSTONIA AND AGITATION. ON (B)(6) 2010, FLUID COULD NOT BE ASPIRATED FROM THE CATHETER. THE PUMP DRUG BACLOFEN DOSAGE WAS DECREASED TO 300 MCG/DAY. THE PT WAS WEANED OFF THE PUMP DRUG AND ORAL BACLOFEN WAS STARTED IN PREPARATION FOR CATHETER EXPLANT. ANTIBIOTICS WERE ADMINISTERED DUE TO A SPINAL INFECTION. THE CATHETER WAS EXPLANTED ON (B)(6) 2010, DUE TO POSSIBLE COMPROMISE AND SPINAL INFECTION. AS OF (B)(6) 2010, THE PATIENT'S OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    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 13 YR Male Required Intervention| O CATHETER: MODEL 8709, LOT# N005269326.| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N005269326| EXPLANTED: