BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1030849 · Received April 17, 2008

    Report

    Report Number
    6000030-2008-02042
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    July 12, 2007
    Report Date
    March 18, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    INTRATHECAL PUMP HISTORY: DETAILS OF INITIAL PUMP IMPLANT WERE NOT AVAILABLE IN CHART MATERIALS. IMPLANT WAS ASSUMED TO HAVE OCCURRED IN 2006 BASED ON A 10/05/2006 PROGRESS NOTE THAT SAYS, "SHE STATES, THAT SHE HAS BEEN WITH THE SAME DOSE INTRATHECALLY SINCE 2006." A POST MYELOGRAM CT SCAN OF THORACIC AND UPPER LUMBAR SPINE TWO MONTHS LATER, SHOWED THE TIP OF THE INTRADURAL CATHETER EXTENDING TO THE LEVEL OF INTERIOR ENDPLATE OF T1. THE PUMP WAS USED TO DELIVER SUFENTANIL, CLONIDINE, AND BUPIVACAINE THROUGHOUT THE COURSE OF HER CARE. THE PATIENT USED A VARIETY OF ORAL AND TOPIC PAIN MEDICATIONS AS NEEDED THROUGHOUT THE CLINICAL COURSE DESCRIBED BELOW, INCLUDING DILAUDID, VALIUM, OXYCODONE, AND DOXEPIN CREAM APPLIED TO KNEES. TWO MONTHS LATER, THE PATIENT REPORTED THAT HER BILATERAL KNEE PAIN WAS STABLE AT 6-8/10. HER DROWSINESS AND FATIGUE HAD INCREASED OVER THE PAST 2 MONTHS; SHE HAD A DECREASE IN HER APPETITE. HER RITALIN WAS DISCONTINUED BECAUSE HER "HEART GETS RACY" AND WAS SUFFERING FROM FATIGUE. SHE DENIED NAUSEA, VOMITING, CONSTIPATION, URINARY HESITANCY, AND PRURITIS SECONDARY TO INTRATHECAL MEDICATIONS. HER MEDICATION DELIVERY RATE WAS DECREASED TO DELIVER SUFENTANIL 1.6191 MG/DAY (WAS 1.811 MG/DAY). PHYSICAL EXAM REVEALED THE PATIENT TO BE ALERT AND ORIENTED. SHE WAS AMBULATORY AND IN NO ACUTE DISTRESS. THERE WAS NO EVIDENCE OF CYANOSIS, CLUBBING, OR EDEMA TO PERIPHERAL EXTREMITIES. THE PUMP WAS FREE FROM SIGNS AND SYMPTOMS OF INFECTION. NO OTHER NEUROLOGICAL CHANGES WERE NOTED. THE NEXT MONTH, THE PATIENT'S BACK PAIN WAS SOMEWHAT WORSE; HER KNEE PAIN WAS VERY BOTHERSOME AND WAS LOCATED MORE IN THE MEDIAL ASPECT RATHER THAN THE REGION OF THE PATELLA. THE PATIENT WAS NOT QUITE AS SLEEPY SINCE PUMP MEDICATIONS WERE DECREASED THE MONTH BEFORE. THE PATIENT MOVED ABOUT THE EXAMINATION AREA WITH MILD-TO-MODERATE PAIN BEHAVIOR. THE PATIENT HAD BILATERAL KNEE INJECTIONS OF 1.5 ML OF 1.5% BUPIVACAINE CONTAINING 20 MG OF DEPO-MEDROL TO TENDER AREAS ALONG MEDIAL ASPECT OF TIBIAL PLATEAU AND LATERAL ASPECT OF KNEE TO LEFT O INFERIOR BORDER OF PATELLA. THE FOLLOWING MONTH, THE PATIENT HAD LOW BACK AND BUTTOCK PAIN (L>R). HER KNEES WERE DOING WELL. THE INFUSION RATE WAS INCREASED TO DELIVER SUFENTANIL 1,7005 MG/DAY FOR BETTER PAIN RELIEF IN LOW BACK. THE HCP PERFORMED A LEFT SACROILIAC JOINT INJECTION OF DEPO-MEDROL 20 MG AND 5 ML OF 0.5% BUPIVACAINE UNDER FLUOROSCOPIC GUIDANCE. TWENTY-FOUR DAYS LATER, THE PATIENT REPORTED THAT THE INTRATHECAL MEDICATION DOSAGE INCREASE PROVIDED SOME RELIEF. HER KNEE PAIN WAS STABLE. THE PATIENT MOVED ABOUT THE EXAM AREA WITH MINIMAL DISPLAYS OF PAIN BEHAVIOR. IN 2007, THE PATIENT REPORTED CONTINUED PAIN IN THE LOWER BACK AND BUTTOCK AREA. A REDUCTION IN PUMP MEDICATION DOSAGE DECREASED HER SLEEPINESS BUT HER OVERALL PAIN LEVEL HAD INCREASED. THE PATIENT MOVED ABOUT EXAM AREA BUT DISPLAYED MILD TO MODERATE PAIN BEHAVIOR, MORE PROMINENT WHEN ARISING FROM A SITTING POSITION. SHE HAD TENDERNESS OVER HER LEFT SACROILIAC JOINT AND UPPER LEFT LATERAL BUTTOCK AREA AND REGION CONSISTENT WITH GLUTEUS MEDIUS PAIN. THE INTRATHECAL SUFENTANIL DOSAGE WAS INCREASED TO 1.8011 MG/DAY. THE PATIENT HAD A LEFT SACROILIAC JOINT INJECTION OF DEPO-MEDROL 20 MG AND 4 ML OF 0.5% BUPIVACAINE DONE UNDER FLUOROSCOPIC GUIDANCE AND A TRIGGER POINT INJECTION TO THE POSTEROLATERAL ASPECT OF LEFT BUTTOCK OF 4 ML OF 0.5% BUPIVACAINE. THE NEXT MONTH, IT WAS REPORTED THAT THE PUMP MEDICATION INCREASED FROM THE LAST VISIT MADE THE PATIENT SOMEWHAT DROWSY. SHE HAD INCREASED KNEE PAIN; THE PATIENT REQUESTED KNEE INJECTIONS. THE PATIENT MOVED ABOUT THE EXAM AREA WITH MINIMAL TO MILD DISPLAYS OF PAIN BEHAVIOR, WELL PROMINENT WHEN ARISING FROM A SITTING POSITION. PALPATION OF BOTH KNEES REVEALED TENDERNESS IN BOTH UPPER AND LOWER ASPECTS OF THE PATELLAE. THE PATIENT HAD DEEP INFRAPATELLAR AND SUPRAPATELLAR BURSAE INJECTIONS OF DEPO-MEDROL 10 MG AND 2 ML OF 0.5% BUPIVACAINE TO RIGHT AND LEFT KNEES. THE FOLLOWING MONTH, THE PATIENT WAS STILL SLEEPY; SHE ALSO HAD FROM VERTIGO. HER PRIMARY CARE DOCTOR HAD PRESCRIBED ANTIVERT THAT SHE FELT CONTRIBUTED TO HER SLEEPINESS. HER KNEE PAIN HAD IMPROVED. THE NEXT MONTH, THE PUMP MEDICATION WAS PROVIDING THE PATIENT WITH RELIEF FOR A PORTION OF HER CHRONIC LOW BACK PAIN. SHE WAS HAVING MORE PAIN IN THE LOWER BUTTOCK AREA. HER RECURRENT BILATERAL KNEE PAIN WAS DEBILITATING AT TIMES. THE PATIENT MOVED ABOUT THE EXAM AREA WITH MINIMAL DISPLAYS OF PAIN BEHAVIOR. SHE APPEARED TO HAVE GAINED SOME WEIGHT OR FLUID. PALPATION OF BOTH KNEES REVEALED TENDERNESS OVER THE MEDIAL ASPECT OF THE PATELLA IN BOTH SUPERIOR AND INFERIOR REGIONS. THE PATIENT HAD BILATERAL SACROILIAC JOINT INJECTIONS OF DEPO-MEDROL 10 MG AND 4 ML OF 0.5% BUPIVACAINE TO THE RIGHT AND LEFT SACROILIAC JOINTS. SHE ALSO HAD INFRAPATELLAR BURSA INJECTIONS OF 10 MG DEPO-MEDROL AND 1.5 ML OF 0.5% BUPIVACAINE UNDER PATELLA AND TO SUPERIOR ASPECT OF BOTH KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J0056653R

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| LOT# NGP007969N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863720