BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4334813 · Received December 16, 2014

    Report

    Report Number
    3007566237-2014-03648
    Event Type
    Injury
    Date Received
    December 16, 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. CONCOMITANT MEDICAL PRODUCTS: 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) FEMALE HAD A 10 DEGREE CONVEXITY TO THE RIGHT AT L1-4 IN 1994. SHE HAD NO PREVIOUS HISTORY OF SPINE SURGERY. SHE HAD AN INITIAL ITOP PLACED IN 2003 FOR SEVERE FIBROMYALGIA ASSOCIATED WITH CHRONIC LOW BACK PAIN. INITIAL RADIOGRAPHS AT THE TIME OF PUMP PLACEMENT SHOWED A 14 DEGREE CONVEXITY TO THE RIGHT AT L1-4. FOUR YEARS FOLLOWING THE PUMP PLACEMENT, RADIOGRAPHS DISPLAYED A PROGRESSION OF SPINAL DEFORMITY TO 41 DEGREE CONVEXITY TO THE RIGHT AT T12-L3. THE RATE OF CHANGE IN SPINAL DEFORMITY PRIOR TO PLACEMENT OF IT PUMP WAS 0.4 DEGREES PER YEAR. AFTER PLACEMENT, THE RATE OF CHANGE INCREASED TO 6.5 DEGREES PER YEAR. SHE UNDERWENT CORRECTION OF HER SPINAL DEFORMITY IN MAY 2007 WITH POSTERIOR SPINE FUSION WITH INSTRUMENTATION FROM T9-L5. SEE ATTACHED LITERATURE ARTICLE IN MANUFACTURER REPORT #3007566237-2014-03646.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823777 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention