BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962198 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00489
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING VARIOUS SYMPTOMS OF AN UNKNOWN ETIOLOGY AND WAS HOSPITALIZED. THE PATIENT'S LOWER EXTREMITY SPASTICITY WAS BEING MANAGED WELL WITH THE USE OF THE INTRATHECAL BACLOFEN THERAPY, BUT THE PATIENT STILL EXPERIENCED LOWER THORACIC ABDOMINAL SPASMS. AT TIMES, THE PATIENT EXPERIENCED BEING "SHORT OF BREATH," WHICH WAS THOUGHT TO BE RELATED TO THE ABDOMINAL SPASMS. IT WAS SUSPECTED THAT THE SHORTNESS OF BREATH MAY BE ASSOCIATED SOME PAIN, PARTICULARLY ON THE PATIENT'S LEFT SIDE. THE PATIENT'S CATHETER TIP WAS AT T5-6 AND THE PHYSICIAN DID NOT THINK THAT THE PLACEMENT OF THE CATHETER OR DRUG DELIVERY SYSTEM HAD ANYTHING TO DO WITH THE PATIENT'S SHORTNESS OF BREATH. AT UNKNOWN TIMES, THE PATIENT HAD BEEN TO THE EMERGENCY ROOM TWICE AND ADMITTED TO THE HOSPITAL ONCE TO RULE OUT CARDIAC ISSUES. DOWN TITRATION OF THE PUMP DOSE AND SUPPLEMENTING THE DRUG WITH ORAL MEDICINE WAS BEING CONSIDERED TO BETTER TREAT THE PATIENT, AS OTHER MEDICAL CAUSES HAD BEEN RULED OUT. IT WAS NOTED THAT THE PATIENT DID HAVE HISTORY OF ANXIETY, BUT DID NOT SEEM TO HAVE THIS ISSUE WHEN ON ORAL BACLOFEN. IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER WAS TREATING THE PATIENT FOR A GENERALIZED ANXIETY DISORDER. THE PATIENT APPEARED "MATERIALLY BETTER" IN REGARD TO REDUCTION OF ABDOMINAL AND LOWER THORACIC SPASMS. THE MEDICATION IN THE PUMP WAS LIORESAL. 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
    65744 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN NEURO CATHETER