BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4192574 · Received October 22, 2014

    Report

    Report Number
    3007566237-2014-03070
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    TSENG, A.S., WEISS, K., HARRISON, T., HANSEN, D., BRUCE, B. PAIN RELIEF AS A PRIMARY TREATMENT GOAL: AT WHAT POINT DOES FUNCTIONING AND WELL-BEING BECOME MORE IMPORTANT? A CASE STUDY OF AN ADOLESCENT WITH DEBILITATING CHRONIC PAIN. PAIN RESEARCH AND MANAGEMENT. 2014;19(4):219-223. SUMMARY: PEDIATRIC CHRONIC PAIN IS A COMMON PROBLEM WITH SIGNIFICANT ECONOMIC IMPLICATIONS AND DEVASTATING CONSEQUENCES ON QUALITY OF LIFE. THE PRESENT REPORT DESCRIBES A CASE INVOLVING A (B)(6) GIRL WITH SEVERE AND DEBILITATING CHRONIC PAIN. BEFORE HER REFERRAL TO A PAIN REHABILITATION PROGRAM, THE PATIENT SAW NUMEROUS SPECIALISTS WHO TREATED HER WITH AN AGGRESSIVE MEDICAL REGIMEN AND TWO SPINAL CORD STIMULATORS. SHE WAS THEN REFERRED FOR INTENSIVE INTERDISCIPLINARY TREATMENT AND, AFTER THREE WEEKS OF REHABILITATION, SHE REPORTED CLINICALLY SIGNIFICANT CHANGES IN ANXIETY, PAIN CATASTROPHIZING AND FUNCTIONAL DISABILITY. THE PATIENT WAS SUCCESSFULLY TITRATED OFF ALL OF HER OPIOID MEDICATIONS AND, EVENTUALLY, BOTH NEUROSTIMULATOR IMPLANTS WERE REMOVED. INTERDISCIPLINARY PAIN REHABILITATION IS A USEFUL TREATMENT FOR PATIENTS WITH CHRONIC PAIN. WITH ITS PRIMARY EMPHASIS ON FUNCTIONAL RESTORATION AS OPPOSED TO STRICTLY PAIN REDUCTION, PATIENTS CAN REGAIN A HIGHER QUALITY OF LIFE WITH REDUCED PAIN AND FEWER MEDICATIONS, SURGERIES AND HOSPITALIZATIONS. REPORTED EVENT: ONE (B)(6) FEMALE PATIENT WITH A HISTORY OF CHRONIC PAIN WAS IMPLANTED WITH A LUMBAR SPINAL CORD STIMULATOR (SCS) 18 MONTHS AFTER ONSET OF PAIN, FOLLOWED BY A CERVICAL SCS DEVICE A FEW MONTHS LATER. THE PATIENT THEN EXPERIENCED A MINIMAL IMPROVEMENT IN PAIN, AND WAS SUBSEQUENTLY PRESCRIBED OTHER MEDICATIONS INCLUDING MULTIPLE OPIOIDS TO TREAT HER ONGOING PAIN. DURING THE COURSE OF THE PATIENT¿S ILLNESS AND TREATMENT, SHE DEVELOPED DEBILITATING FATIGUE AND DEPRESSION WITH OCCASIONAL THOUGHTS OF SUICIDE. THE PATIENT REPORTED A DIMINISHED ABILITY TO PARTICIPATE IN SOCIAL FUNCTIONS. FURTHERMORE, THE PATIENT GAINED 35 POUNDS AND DEVELOPED DIFFICULTIES WITH URINATION AND DEFECATION, ISSUES POSSIBLY ASSOCIATED WITH HER MEDICATIONS AND OTHER LIFESTYLE CHANGES (EG. INCREASE IN SEDENTARY BEHAVIOR). THE PATIENT WAS ONLY ABLE TO PASS STOOLS DURING SLEEP WHEN HER BODY WAS SUFFICIENTLY RELAXED, RESULTING IN FREQUENT SOILING OF HER BED. AS THE PAIN PROGRESSED, THE PATIENT BECAME BEDRIDDEN. THE PATIENT BECAME PROGRESSIVELY MORE DISABLED AND EVENTUALLY WAS UNABLE TO PERFORM BASIC ACTIVITIES OF DAILY LIVING DUE TO HER PAIN. THE PATIENT THEN ENTERED INTO AN OUTPATIENT PEDIATRIC PAIN REHABILITATION PROGRAM, AT WHICH POINT SHE WAS USING A CANE TO WALK AND WORE SANDALS THAT WOULD NOT EXACERBATE HER FOOT AND TOE PAIN. DURING INTAKE ASSESSMENTS, ALTHOUGH ORIENTED TO TIME AND PLACE, THE PATIENT WAS FATIGUED AND FELL ASLEEP MULTIPLE TIMES DURING CONSULTATION. THE PATIENT¿S MOOD WAS DYSPHORIC AND AFFECT WAS FLAT. HER THOUGHT PROCESSES WERE TANGENTIAL AND CONTENT WAS APPROPRIATE TO SESSION. THE PATIENT¿S SPEECH WAS SLOW AND SLURRED. EYE CONTACT WAS LACKING AT TIMES BECAUSE SHE HAD DIFFICULTY KEEPING HER EYES OPEN. THE PATIENT WAS REPORTEDLY MOTIVATED TO DECREASE MEDICATIONS AND LEARN COPING SKILLS TO MANAGE PAIN AND RETURN TO REGULAR FUNCTIONING. THE PATIENT WAS GRADUALLY ABLE TO TAPER OFF ALL OPIOID MEDICATIONS AS WELL AS SLEEP MEDICATIONS. THE PATIENT¿S MENTAL STATUS GRADUALLY IMPROVED AND SHE WAS MORE FULLY ABLE TO PARTICIPATE IN DAILY PROGRAMMING AND INTERACTIONS WITH HER PEERS. WITHIN ONE WEEK, THE PATIENT WAS ABLE TO WALK WITHOUT HER CANE. INITIALLY, THE PATIENT HAD EXTREME DIFFICULTY WITH COMPLIANCE WITH WEARING SOCKS AND SHOES DUE TO ALLODYNIA. HOWEVER, BY THE SECOND WEEK OF THERAPY, SHE WAS ABLE TO WEAR SHOES FULL TIME. THE PATIENT WAS ASKED TO TURN OFF THE SCS DEVICES FOR SHORT PERIODS OF TIME AND TO USE THE COPING STRATEGIES SHE WAS LEARNING TO MANAGE ANY SYMPTOMS. THE PATIENT COMPLIED, BUT EXPERIENCED INCREASED ANXIETY WHILE DOING SO AND WAS NOT ABLE TO DISCONTINUE THE USE OF THE NEUROSTIMULATORS WHILE IN THE THREE-WEEK PROGRAM. THE PATIENT WAS ENCOURAGED TO CONSIDER WEANING OFF THE NEUROSTIMULATORS AT SOME POINT IN THE FUTURE WHEN SHE BELIEVED HER COPING SKILLS WERE MORE SOLIDIFIED. BY THE END OF THIS PROGRAM, THE PATIENT REPORTED CLINICALLY SIGNIFICANT DECREASES IN PAIN CATASTROPHIZING, ANXIETY, AND FUNCTIONAL DISABILITY. AT THE SIX-MONTH FOLLOW-UP, THE PATIENT REPORTED AN ABSENCE OF PAIN, PAIN CATASTROPHIZING, AND FUNCTIONAL DISABILITY. DEPRESSION AND ANXIETY SYMPTOMS WERE IN THE NONCLINICAL RANGE. THE PATIENT WAS ALSO SUCCESSFULLY TITRATED OFF ALL NARCOTIC MEDICATIONS AND MOST SLEEP MEDICATION BY DISCHARGE AND BY THREE AND SIX MONTHS FOLLOW-UPS. ONE YEAR LATER, THE PATIENT CONTINUED TO DO WELL AND WAS INVOLVED IN EXTRACURRICULAR ACTIVITIES AND RETURNED TO HER NORMAL WEIGHT. THE REPORTER STATED THAT EVENTUALLY, THE PATIENT DECIDED THE NEUROSTIMULATORS BOTHERED HER AND DECIDED TO HAVE THEM BOTH REMOVED, DESPITE SOME HESITATION FROM HER MEDICAL PROVIDERS AT HOME DUE TO CONCERNS ABOUT RELAPSE. IT WAS REPORTED THAT THE PATIENT RETURNED TO HER BASELINE LEVEL OF FUNCTIONING BEFORE PAIN ONSET AND WAS ABLE TO PERFORM ALL ACTIVITIES OF DAILY LIVING. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671969 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Life Threatening| R