BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4339038 · Received December 17, 2014

    Report

    Report Number
    3007566237-2014-03665
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    DANIEL, J.W., HAFT, G.F. PROGRESSIVE ADULT SPINAL DEFORMITY FOLLOWING PLACEMENT OF INTRATHECAL OPIOID PUMP: A REPORT OF FOUR CASES. THE IOWA ORTHOPAEDIC JOURNAL. 2014; 34: 144-149. SUMMARY: PLACEMENT OF INTRATHECAL OPIOID PUMPS (ITOP) FOR CHRONIC PAIN IS A RARE, BUT DESCRIBED CAUSE OF PROGRESSIVE SPINAL DEFORMITY. OVER THE LAST TWO DECADES THERE HAS BEEN SEVERAL SUSPECTED CASES AT OUR INSTITUTION. IN THIS CASE SERIES, WE DESCRIBED THE APPARENT ASSOCIATION BETWEEN PLACEMENT OF AN INTRATHECAL OPIOID PUMP AND PROGRESSION OF SPINAL DEFORMITY. THE MEDICAL RECORDS OF A SINGLE SURGEON WORKING AT A SINGLE INSTITUTION WERE RETROSPECTIVELY QUERIED FOR PATIENTS SEEN BETWEEN 1995-2010 TO IDENTIFY PATIENTS WITH SPINAL DEFORMITY AND AN ITOP. ALL HOSPITAL RECORDS INCLUDING NOTES, RADIOGRAPHS, AND LABS WERE REVIEWED AND ANALYZED. SPINE RADIOGRAPHS WERE MEASURED USING STANDARD TECHNIQUES AND REPORTED AS COBB ANGLES. THIS PROJECT WAS IRB APPROVED AND NO EXTERNAL FUNDING WAS USED. IN TOTAL, WE IDENTIFIED FOUR PATIENTS WITH SPINAL DEFORMITY AFTER PLACEMENT OF AN ITOP. THESE PATIENTS WERE ADULTS, TWO MALES AND TWO FEMALES (AGES: 48-80 YEARS), WITH A UNIQUE MEDICAL HISTORY. EACH PARTICIPANT¿S RADIOGRAPHS SHOWED A PROGRESSION OF THE SPINAL DEFORMITY FOLLOWING PLACEMENT OF ITOP. ALL PATIENTS UNDERWENT SUBSEQUENT POSTERIOR SPINAL FUSION FOR TREATMENT OF THEIR PROGRESSIVE SPINAL DEFORMITIES. IN THIS SERIES, WE HAVE SHOWN AN APPARENT ASSOCIATION BETWEEN THE PLACEMENT OF ITOP AND PROGRESSION OF DEFORMITY IN BOTH PATIENTS WITH AND WITHOUT EXISTING SPINAL DEFORMITY. WHILE IT IS IMPOSSIBLE TO DISCERN CAUSALITY, ALL PATIENTS IN OUR SERIES HAD RADIOGRAPHIC AND CLINICAL EVIDENCE OF SPINAL DEFORMITY PROGRESSION AFTER PLACEMENT OF INTRATHECAL PUMPS. THESE FINDINGS MAY RAISE AWARENESS OF THIS RARE, BUT MAJOR, COMPLICATION. IN THOSE PERFORMING PUMP PLACEMENT, WE RECOMMEND CONTINUED CLINICAL AND RADIOGRAPHIC MONITORING, THROUGH ROUTINE FOLLOW-UP. REPORTED EVENT: A (B)(6) YEAR-OLD MALE HAD NO PREVIOUS HISTORY OF SPINAL DEFORMITY. HE HAD AN EXTENSIVE HISTORY OF LOW BACK PAIN FOR WHICH HE HAD PLACEMENT OF SPINAL CORD STIMULATOR (SCS) IN 1998. IN 2000, HE HAD HIS SCS REMOVED AND UNDERWENT PLACEMENT OF AN ITOP FOR CHRONIC LOW BACK PAIN. PRE-PUMP RADIOGRAPHS WERE DESTROYED BY THE HEALTH SYSTEM AS PART OF THEIR ROUTINE MANAGEMENT OF FILMS OLDER THAN SEVEN YEARS. IN 2004, HE HAD A 21 DEGREE COBB ANGLE TO THE RIGHT FROM T12-L4. HE HAD TWO REVISIONS OF HIS IT PAIN PUMP IN 2006 AND 2007 DUE TO DEVICE MALFUNCTION. SUBSEQUENT RADIOGRAPHS IN EARLY 2007 SHOWED NO SIGNIFICANT PROGRESSION WITH A 23 DEGREE CONVEXITY TO THE RIGHT AT THE SAME LEVELS. LATER IN 2007, HE HAD A SIGNIFICANT PROGRESSION OF HIS SPINAL DEFORMITY TO A 38 DEGREE CONVEXITY TO THE RIGHT AT T12-L4. HIS RATE OF CHANGE FROM 2004 TO 2006 WAS 3.5 DEGREES PER YEAR, BUT FOLLOWING THE FIRST REVISION OF HIS ITOP, HIS PROGRESSION RATE INCREASED TO 10 DEGREES FROM 2006 TO 2007. HE UNDERWENT CORRECTIVE SURGERY WITH POSTERIOR SPINAL FUSION AND INSTRUMENTATION FROM T9-L5 IN DECEMBER 2007 FOR HIS PROGRESSIVE SPINAL DEFORMITY. SEE MANUFACTURER REPORTS #3007566237-2014-03659 AND 3007566237-2014-03658 FOR THE 2006 AND 2007 PAIN PUMP MALFUNCTIONS RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828476 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention