BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 506516 · Received January 12, 2004

    Report

    Report Number
    6000030-2004-00024
    Event Type
    Injury
    Date Received
    January 12, 2004
    Report Date
    December 10, 2003
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PT PRESENTED WITH SIGNS OF AN INFLAMMATORY MASS AT THE TIP OF THE CATHETER. THESE SIGNS INCLUDED AN INCREASE IN PAIN, AND "PROGRESSIVE WEAKNESS IN HIS EXTREMITIES TIMES FOUR." AN MRI WAS DONE WHICH SHOWED SEVERE SPINAL STENOSIS AT T2-3 AND T3-4 DUE TO BOTH INFLAMMATORY/HEMORRHAGIC EFFECT ABOUT THE TIP OF THE SPINAL CATHETER AND POSTERIOR DISC HERNIATION. THE PUMP WAS STOPPED IN 12/2003. THE PT WAS THEN GIVEN DURAGESIC PATCHES AND PRESCRIBED ORAL PAIN MEDICATION. ON 12/2003 THE PT HAD A POSTERIOR CERVICAL DECOMPRESSION, A LEFT T12-L1 HEMILAMINECTOMY, AND REMOVAL OF THE INTRATHECAL CATHETER. MULTIPLE SPECIMENS AND CULTURES WERE TAKEN OF THE LIGAMENTUM FLAVUM DUE TO IT'S "GRAYISH APPEARNACE." THE FROZEN SECTION (UNK SOURCE) WAS REPORTED AS "CHRONIC INFLAMMATORY OR GRANULATION TISSUE WITHOUT EVIDENCE OF POLYMORPHNUCLEUR CELLS." NO PT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED CATHETER LKK RICE CREEK MFG 8703 J93117895

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization EXPLANTED: UNK.| PUMP MODEL 862718 LOT# NGF028110R IMPLANTED: 2002,