BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013180 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00840
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8731, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO (B)(6) 2011 THE PATIENT'S PAIN WAS A 7 OUT OF 10 ON A PAIN SCALE. HOWEVER, IN (B)(6) 2011 THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM THREE DAYS IN A ROW. THE PATIENT REPORTED EXPERIENCING FLU-LIKE SYMPTOMS. A MASSIVE HEADACHE AND FEVER, NECK AND BACK PAIN, SINUS PRESSURE, SWOLLEN TONGUE, DRY MOUTH, AND THE SMELL OF METAL AND TASTE OF "ALL SORTS OF METALS" WERE PRESENT. THE PATIENT'S PAIN INCREASED TO 20 OUT OF 10 ON THE PAIN SCALE. THE PATIENT REPORTED A COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN WAS DONE AND A BLOOD CLOT WAS RULED OUT. IT WAS TOLD TO THE PATIENT THAT THE PUMP WAS NOT WORKING RIGHT AND THE PUMP WAS REPLACED. THE CLINICIAN RECENTLY REPORTED THAT AT SOME POINT ALL OF THE SYMPTOMS HAD BEEN INVESTIGATED BY NUMEROUS SPECIALISTS ACROSS DIFFERENT STATES AND NO ONE HAD AN ANSWER FOR THE PATIENT'S SYMPTOMS. MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTERIZED TOMOGRAPHY (CT) SCANS OF THE WHOLE BODY AND SINUS CAVITIES WERE DONE AT SOME POINT ALL WITH NORMAL RESULTS. IT WAS NOT KNOWN WHAT MEDICATION THE DEVICE SYSTEM HAD DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116545 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention