BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID EPIDURAL CATHETER KIT

    MDR report key: 39770 · Received September 23, 1996

    Report

    Report Number
    1219454-1996-00439
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 23, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 8/26/96 REF (MDR#: 1219454-1996-00438), FOR INTRATHECAL INFUSION OF DURAMORPH FOR TREATMENT OF PAIN (NOTE: INTRATHECAL PLACEMENT OF THE DEVICE IS NOT A MFR'S INDICATION FOR THE DEVICE'S INTENDED USE). ON 9/11/96, THE PT WAS RETURNED TO THE OPERATING ROOM WITH PURULENT DRAINAGE FROM AN INCISION AT THE LUMBAR REGION OF THE SPINE FROM THE DEVICE IMPLANT SURGERY PERFORMED ON 8/26/96. THE IMPLANTING SURGEON WAS ON VACATION. A NEUROSURGEON AND THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE REMOVED THE IMPLANTABLE INFUSION PUMP AND THE ATTACHED INTRATHECAL CATHETER DUE TO AN INFECTION AT THE LUMBAR REGION. THE NEUROSURGEON STATED THAT HE REMOVED SOME NECROTIC TISSUE FROM SKIN AT THE LUMBAR REGION, HE DID NOT WANT THE INFECTION TO TRACK DOWN THE INTRASPINAL CATHETER TO THE IMPLANTABLE INFUSION PUMP POCKET, SO THE NEUROSURGEON ELECTED TO REMOVE BOTH THE INTRATHECAL CATHETER AND THE IMPLANTABLE INFUSION PUMP. THE NEUROSURGEON ALSO STATED THAT HE FELT THAT THE TISSUE INFECTION WAS LOCALIZED AT THIS TIME. THE IMPLANTING SURGEON'S PARTNER/ASSOCIATE STATED IN HER PROGRESS NOTES THAT THE DEVICE WAS FUNCTIONING WITHOUT DIFFICULTY AND THE INTRATHECAL CATHETER WAS INTACT UPON REMOVAL. THE PHYSICIANS DID NOT WANT THE IMPLANTABLE INFUSION PUMP OR THE CATHETER TO BE ANALYZED SINCE THEY FELT THAT THE EXPLANT WAS DUE TO AN INFECTION AT THE LUMBAR REGION, NOT TO EITHER THE PUMP AND/OR THE CATHETER TO BE ANALYZED SINCE THEY FELT THAT THE EXPLANT WAS DUE TO AN INFECTION AT THE LUMBAR REGION, NOT TO EITHER THE PUMP AND/OR THE CATHETER. THE DEVICE AND THE CATHETER WERE REMOVED TO PREVENT SPREAD OF THE INFECTION AND POTENTIAL COMPLICATIONS. THE NEUROSURGEON STATED THAT THERE WAS A SMALL PIECE OF EPIDURAL CATHETER IN THE DURA SPACE FROM THE PREVIOUS INSERTION (8/26/96, SEE MDR#1219454-1996-00438), BUT HE CHOSE TO LEAVE THIS PORTION OF THE EPIDURAL CATHETER IN THE DURA SPACE TO PREVENT THE PT FROM FURTHER EXPOSURE TO INFECTION. THE CATHETER THAT WAS ATTACHED TO THE IMPLANTABLE INFUSION PUMP AND THE INTRATHECAL CATHETER THAT WAS EXPLANTED WERE INTACT AND NO TEARS OR BREAKAGE WERE NOTED. THE PHYSICIANS DO NOT WANT ANY FURTHER FOLLOW-UP PERFORMED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID EPIDURAL CATHETER KIT Implant EPIDURAL CATHETER KIT CAZ STRATO/INFUSAID, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention