BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1850827 · Received September 28, 2010

    Report

    Report Number
    6000030-2010-07395
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S ENTIRE SYSTEM WAS REPLACED. THE BATTERY WAS DEPLETED AND THE PUMP WAS SCHEDULED TO BE REPLACED BUT THERE ORIGINALLY WERE NO PLANS FOR THE CATHETER. WHEN THE PUMP WAS EXPOSED, THE EXISTING PUMP CONNECTOR WAS STILL ATTACHED BUT NO TIE WAS IN PLACE. IT APPEARED THAT THE LIP OF THE CONNECTOR HAD SPLIT WITH CRYSTALLIZED MATERIAL COVERING PART OF THE PUMP CONNECTOR. ONCE DISCONNECTED THERE WAS NO CEREBROSPINAL FLUID (CSF). DURING A FLUORO EXAM, THE CATHETER APPEARED TO BE AT THE LEVEL OF T12 AND IN THE EPIDURAL SPACE. ONCE THE SPINAL SECTION WAS EXPOSED THERE WAS NO ANCHOR FOUND, THE CATHETER WAS CUT AND AGAIN NO CSF. A PURSE STRING SUTURE WAS PLACED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE SPINAL SECTION OF THE CATHETER RESULTING IN A FRACTURE. A SMALL PART OF THE CATHETER WAS PULLED OUT BUT A PORTION WAS LEFT IN THE TISSUE. THERE WAS NO CSF LEAK FOUND AT THE SITE. THE EXPLANTED PUMP WAS CHECKED AND THE VOLUME WAS ACCURATE WITH THE PROGRAMMER READING. THE PT WAS ON ORAL NARCOTICS AS WELL AS THE IMPLANTABLE DRUG DELIVERY SYSTEM (IDDS) DOSE. THE EXISTING CATHETER APPEARED TO BE ON THE RIGHT SIDE OF THE SPINE WITH THE PUMP POCKET IN THE LEFT LOWER ABDOMEN. A NEW CATHETER WAS PLACE WITH GOOD CSF FLOW, TUNNELED AND CONNECTED TO A NEW PUMP. AFTER THE SURGERY, THE PT'S MEDICATION DOSES WERE REDUCED TO 1.44 MG/DAY OF DILAUDID, 0.96 MG/DAY BUPIVICAINE, AND 14.4 MCG/DAY OF BACLOFEN AND ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PUMP CONTAINED DILAUDID AT A CONCENTRATION OF 30 MG/ML, COMPOUNDED BACLOFEN AT A CONCENTRATION OF 300 MCG/ML AND BUPIVICAINE AT A CONCENTRATION OF 20 MG/ML. IT WAS LATER REPORTED THE PT WAS DISCHARGED FROM THE HOSPITAL WITH NO PROBLEMS WITH THE PUMP OR DOSE. THE PT WAS ON ORAL MEDICATION AS WELL AS INTRATHECALLY. THE PT RECOVERED W/O SEQUELA. THE SURGEON NOTED THE PT WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL W/O PROBLEMS WITH THE PUMP OR THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J10901R48| EXPLANTED: