BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4334738 · Received December 16, 2014

    Report

    Report Number
    3007566237-2014-03646
    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: AN (B)(6) FEMALE WITH HISTORY OF OSTEOPOROSIS, HAD NO SPINAL DEFORMITY PRIOR TO SPINE SURGERY. SHE UNDERWENT A L3-4 AND L4-5 MICRODISKECTOMY AND POSTERIOR LUMBAR INTERBODY FUSION WITH TITANIUM CAGES IN 1997. SHE ALSO HAD ANTERIOR CERVICAL DISCECTOMY AND FUSION OF C4-5, C5-6, AND C6-7 IN 1998. IN JUNE 2005, SHE UNDERWENT ANOTHER SPINE SURGERY WHICH INCLUDED A RIGHT L2-3 FORAMINOTOMY AND L2-3 POSTEROLATERAL FUSION WITH AUTOLOGOUS ILIAC CREST BONE GRAFT AND PEDICLE SCREW INSTRUMENTATION. INITIAL RADIOGRAPHS AFTER THE (B)(6) 2005 SURGERY SHOWED A 17 DEGREE CONVEXITY TO THE RIGHT AT L1-4. SUBSEQUENT RADIOGRAPHS IN 2005 AND 2006 SHOWED NO CHANGE FROM INITIAL MEASUREMENTS. SHE HAD AN ITOP PLACED IN (B)(6) 2006 FOR CHRONIC POST-SURGICAL LOW BACK PAIN OR SO-CALLED ¿FAILED BACK SYNDROME¿. FOLLOW-UP RADIOGRAPHS IN (B)(6) 2007 BEGAN TO SHOW PROGRESSION OF SPINAL DEFORMITY WITH AN INCREASE TO 25 DEG REE CONVEXITY TO THE RIGHT AT L1-4. FOUR MONTHS LATER, HER SPINAL DEFORMITY PROGRESSED TO 42 DEGREES AT L1-4. THE RATE OF CHANGE IN SPINAL DEFORMITY PRIOR TO PLACEMENT OF IT PUMP WAS 1.1 DEGREES PER YEAR. AFTER PLACEMENT, THE RATE OF CHANGE INCREASED TO 12.5 DEGREES PER YEAR. SHE UNDERWENT CORRECTION OF HER SPINAL DEFORMITY IN JULY 2008 WITH POSTERIOR SPINAL FUSION OF T6-S1 WITH INSTRUMENTATION AND EXTENSION TO THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823928 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention