BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 8741163 · Received June 27, 2019

    Report

    Report Number
    3007566237-2019-01410
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    November 19, 2018
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VARGOVICH, A. M, CHORNEY, J., GROSS, R. T., VOWLES, K. E. CHRONIC PAIN REHABILITATION FOR UPPER EXTREMITY PAIN FOLLOWING STIMULATOR REMOVAL. AM J CASE REP. 2018. 19: 1373-1377. DOI: 10.12659/AJCR.911157. SUMMARY: BOTH SPINAL CORD STIMULATORS (SCS) AND INTERDISCIPLINARY CHRONIC PAIN REHABILITATION PROGRAM (CPRP) ARE EVIDENCE-BASED TREATMENTS FOR CHRONIC PAIN BUT DIFFER ON TREATMENT FOCI. SCS FOCUSES ON DECREASING THE SUBJECTIVE PAIN EXPERIENCE AS A MEANS OF IMPROVING FUNCTION AND QUALITY OF LIFE. CPRP FOCUSES ON ADDRESSING THE COGNITIVE, EMOTIONAL, AND BEHAVIORAL FACTORS ASSOCIATED WITH CHRONIC PAIN TO IMPROVE FUNCTION. DUE TO EXPERIMENTAL CONSTRAINTS, THESE 2 TREATMENT OPTIONS ARE DIFFICULT TO COMPARE; HOWEVER, THIS CASE REPORT OFFERS A UNIQUE OPPORTUNITY TO EXAMINE OUTCOMES FOR BOTH INTERVENTIONS IN A SEQUENTIAL MANNER FOR CHANGES IN PAIN, FUNCTION, AND MOOD. THIS SINGLE CASE STUDY EXAMINED THE SEPARATE AND SEQUENTIAL OUTCOMES OF SCS AND CPRP IN A (B)(6)-YEAR-OLD PATIENT WITH A WORK-RELATED INJURY RESULTING IN CHRONIC UPPER EXTREMITY PAIN. THIS PATIENT WAS TREATED WITHIN AN INTERDISCIPLINARY CPRP FOLLOWING FAILURE AND REMOVAL OF AN SCS. OUTCOMES WERE MEASURED BY PSYCHOLOGICAL ASSESSMENTS AND RETURN-TO-WORK THROUGH A 6-MONTHS POST-CPRP FOLLOW-UP. PAIN INTENSITY DECREASED FOLLOWING SCS PLACEMENT AND CPRP, WHILE PAIN-RELATED DISTRESS, PAIN INTERFERENCE, AND OVERALL AFFECT IMPROVED ONLY AFTER CPRP, WITH SUSTAINED IMPROVEMENTS AT 6-MONTHS FOLLOW-UP. PATIENT EVIDENCED- IMPROVEMENT FOLLOWING TREATMENT WITH SCS AND CPRP. SCS RESULTED IN IMPROVEMENT IN SUBJECTIVE PAIN AND MODEST IMPROVED SELF-REPORTED ACTIVITY. CPRP DEMONSTRATED MARKED IMPROVEMENT IN PAIN, SELF-REPORTED FUNCTION, AND MOOD WITH PATIENT EVENTUALLY RETURNING TO WORK AND MAINTAINING MOST OF THESE GAINS 6-MONTHS AFTER COMPLETING CPRP TREATMENT. REPORTED EVENT: ONE YEAR FOLLOWING HER INJURY, A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A CARPEL TUNNEL RELEASE WITH LITTLE IMPROVEMENT. A TEMPORARY DORSAL COLUMN SCS WAS IMPLANTED WITH COMPLETE REMISSION OF SYMPTOMS AND A PERMANENT SCS WAS PLACED 16-MONTHS POST-INJURY. A REFERRAL TO A CHRONIC PAIN REHABILITATION PROGRAM (CPRP) WAS MADE AT THIS TIME WITH THE GOAL OF IMPROVED FUNCTION AND PAIN COPING. THE PATIENT WAS FOUND TO BE AN APPROPRIATE CANDIDATE FOR REHABILITATION, BUT HER ADMISSION TO THE CPRP WAS DELAYED UNTIL SHE WAS RECOVERED FROM SURGERY. DURING THIS PERIOD, IT BECAME APPARENT THAT, IN CONTRAST TO THE TEMPORARY PLACEMENT, THE PERMANENT STIMULATOR DID NOT RELIEVE THE PATIENT¿S PAIN SIGNIFICANTLY. THE STIMULATOR WAS REMOVED 3-MONTHS POST-IMPLANTATION, 19-MONTHS POST-INJURY. WITH PERSISTENT COMPLAINTS, THE PATIENT WAS RE-EVALUATED FOR CPRP PARTICIPATION AND WAS ADMITTED TO THE PROGRAM 24-MONTHS POST-INJURY (8-MONTHS POST-SCS IMPLANTATION; 5-MONTHS POST-SCS REMOVAL). NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533626 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention