BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION

    MDR report key: 6712965 · Received July 13, 2017

    Report

    Report Number
    3007566237-2017-02868
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    September 26, 2016
    Report Date
    July 13, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE MAIN COMPONENT OF THE SYSTEM FROM THE FIRST EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ABRECHT CR, GREENBERG P, SONG E, URMAN RD, RATHMELL JP. A CONTEMPORARY MEDICOLEGAL ANALYSIS OF IMPLANTED DEVICES FOR CHRONIC PAIN MANAGEMENT. ANESTHESIA ANALGESIA. 2017;124(4):1304-1310. DOI: 10.1213/ANE.0000000000001702 SUMMARY: BACKGROUND: ANALYSIS OF CLOSED MALPRACTICE CLAIMS ALLOWS THE STUDY OF RARE BUT SERIOUS COMPLICATIONS AND LIKELY RESULTS IN IMPROVED PATIENT SAFETY BY RAISING AWARENESS OF SUCH COMPLICATIONS. CLINICAL STUDIES AND CLOSED CLAIMS ANALYSES HAVE PREVIOUSLY REPORTED ON THE COMMON COMPLICATIONS ASSOCIATED WITH INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) AND SPINAL CORD STIMULATORS (SCS). THIS STUDY PROVIDES A CONTEMPORARY ANALYSIS OF CLAIMS FROM WITHIN THE PAST 10 YEARS. METHODS: WE PERFORMED A CLOSED CLAIMS ANALYSIS FOR A PERIOD JANUARY 1, 2009 TO DECEMBER 31, 2013 FOR CASES WITH PAIN MEDICINE AS THE PRIMARY SERVICE. THESE CASES WERE IDENTIFIED USING THE CONTROLLED RISK INSURANCE COMPANY (CRICO) COMPARATIVE BENCHMARKING SYSTEM (CBS), A DATABASE CONTAINING MORE THAN 300,000 MALPRACTICE CLAIMS FROM MORE THAN 400 ACADEMIC AND COMMUNITY INSTITUTIONS, REPRESENTING APPROXIMATELY 30% OF MALPRACTICE CASES IN THE UNITED STATES. THE CLINICAL NARRATIVES, WHICH INCLUDED MEDICAL FILES, CLAIMS FILES, DEPOSITIONS, AND EXPERT WITNESS TESTIMONY, WERE REVIEWED BY THE AUTHORS, AS WERE THE CRICO CODED VARIABLES, WHICH INCLUDED ALGORITHMICALLY DETERMINED CONTRIBUTING FACTORS TO THE PATIENT INJURY. RESULTS: INTRATHECAL DRUG DELIVERY SYSTEMS REPRESENTED 17 OF THE CLOSED CLAIMS; SPINAL CORD STIMULATORS REPRESENTED 11 OF THE CLOSED CLAIMS. THE MOST COMMON CHRONIC PAIN DIAGNOSES FOR WHICH A DEVICE WAS IMPLANTED INCLUDED FAILED BACK SURGERY SYNDROME AND SPASTICITY. THE AVERAGE TOTAL INCURRED FOR PAIN MEDICINE CLAIMS WAS $166,028. DAMAGING EVENTS INCLUDED IDDS REFILL ERRORS (EG, SUBCUTANEOUS ADMINISTRATION OF MEDICATION, REPROGRAMMING ERRORS), INTRAOPERATIVE NERVE DAMAGE, AND POSTOPERATIVE INFECTION (EG, EPIDURAL ABSCESS, MENINGITIS). HIGH-SEVERITY OUTCOMES INCLUDED NERVE DAMAGE (EG, PARAPLEGIA) AND DEATH. MEDIUM-SEVERITY OUTCOMES INCLUDED DRUG REACTIONS (EG, RESPIRATORY ARREST FROM OPIOID OVERDOSE) AND THE NEED FOR REOPERATION. FOR BOTH IDDS AND SCS, DEFICITS IN TECHNICAL SKILL WERE THE MOST COMMON CONTRIBUTING FACTOR TO INJURY, FOLLOWED BY DEFICITS IN CLINICAL JUDGMENT, COMMUNICATION, AND DOCUMENTATION. CONCLUSIONS: IMPLANTED DEVICES USED FOR PAIN MANAGEMENT INVOLVE A SIGNIFICANT RISK OF MORBIDITY AND MORTALITY. PROPER EDUCATION OF P ROVIDERS AND PATIENTS IS ESSENTIAL. PROVIDERS MUST ACQUIRE THE TECHNICAL SKILLS REQUIRED FOR THE IMPLANTATION AND REFILLING OF THESE DEVICES AND THE CLINICAL SKILLS REQUIRED FOR THE IDENTIFICATION AND MANAGEMENT OF COMPLICATIONS SUCH AS INTRATHECAL GRANULOMA. PROPER PATIENT SELECTION AND CLEAR COMMUNICATION BETWEEN THE PROVIDER AND THE PATIENT ABOUT THESE POSSIBLE COMPLICATIONS ARE OF PARAMOUNT IMPORTANCE. REPORTED EVENTS: THREE(3) PATIENTS IMPLANTED WITH SPINAL CORD STIMULATORS (SCSS) EXPERIENCED A ¿POST-OP INFECTION.¿ IT WAS NOTED THAT ¿POSTOPERATIVE INFECTION DAMAGING EVENTS INCLUDED SOFT TISSUE AND EPIDURAL ABSCESS FORMATION RELATED MOST OFTEN TO THE INFECTION SURROUNDING A DEVICE COMPONENT.¿ TWO (2) PATIENTS IMPLANTED WITH SCSS HAD A REPORTED OUTCOME OF ¿NERVE DAMAGE.¿ THE REPORTED NERVE DAMAGE CASES WERE DEEMED ¿HIGH-SEVERITY¿ IN NATURE AND WERE RATED AS A 6-9 ON THE 0-9 NATIONAL ASSOCIATION OF INSURANCE COMMISSIONERS (NAIC) SCALE. IT WAS NOTED THAT A 6-9 SCORE ¿REPRESENTED DEATH AND OTHER PERMANENT MAJOR OUTCOMES.¿ SOME CAUSES OF REPORTED NERVE DAMAGE WERE INTRAOPERATIVE INJURY OR INFECTION. ADDITIONALLY, THE AUTHORS NOTED THAT AN EXAMPLE OF HIGH-SEVERITY NERVE DAMAGE WAS PARAPLEGIA; HOWEVER, THERE WAS NO SPECIFIC INDICATION THAT ANY OF THESE TWO PATIENTS EXPERIENCED PARAPLEGIA. ONE (1) PATIENT IMPLANTED WITH A SCS EXPERIENCED INTRAOPERATIVE NERVE DAMAGE. THE PATIENT UNDERWENT THE ¿UNEVENTFUL PLACEMENT OF A SCS UNDER MONITORED ANESTHESIA CARE, AFTER WHICH THE PATIENT DEVELOPED PERMANENT LEFT LOWER EXTREMITY WEAKNESS, DETERMINED LATER BY COMPUTED TOMOGRAPHIC MYELOGRAM AND A NEUROLOGY CONSULTANT TO BE BROWN SEQUARD SYNDROME LIKELY BECAUSE OF TRAUMATIC INSERTION OF THE LEAD.¿ TWO (2) PATIENTS IMPLANTED WITH SCSS HAD A REPORTED OUTCOME OF ¿NEED FOR RE-OP.¿ THE REPORTED CASES WERE DEEMED ¿MEDIUM-SEVERITY¿ IN NATURE AND WERE RATED AS A 3-5 ON THE 0-9 NAIC SCALE. IT WAS NOTED THAT A 3-5 SCORE ¿REPRESENTED TEMPORARY MAJOR AND PERMANENT MINOR OUTCOMES.¿ THE AUTHORS ADDED THAT THE NEED FOR REOPERATION WAS ¿MOST COMMONLY BECAUSE OF THE RETAINED DEVICE COMPONENT OR INFECTION.¿ THREE (3) PATIENTS IMPLANTED WITH SCSS EXPERIENCED A ¿INTRA-OP NERVE DAMAGE.¿ THESE CASES INVOLVED ¿TRANSIENT WEAKNESS OR TRANSIENT WORSENING PAIN AFTER UNEVENTFUL SCS TRIALS WITH NO IMAGING SUPPORTING ANY NEURAXIAL DAMAGE AND WHICH WERE DISMISSED.¿ TWO (2) PATIENTS IMPLANTED WITH SCSS EXPERIENCED THE ¿IMPROPER TECHNICAL PLACEMENT OF [THE] DEVICE.¿ THE CONTRIBUTING FACTORS, AS CODED BY CRICO (CONTROLLED RISK INSURANCE COMPANY), WERE NOTED AS 8 CASES OF TECHNICAL SKILL, 5 CASES OF CLINICAL JUDGEMENT, 2 CASES OF COMMUNICATION, 2 CASES OF DOCUMENTATION, 2 CASES OF PATIENT BEHAVIOR, 2 CASES OF SUPERVISION OF STAFF OR SUPERVISION OF TRAINEE, 3 CASES OF EQUIPMENT-RELATED, AND ONE CASE OF NO RISK MANAGEMENT ISSUES IDENTIFIED. IT WAS NOTED THAT 1 CASE HAD NO FACTORS, 5 CASES HAD 1 FACTOR, 11 CASES HAD 2 FACTORS, 5 CASES HAD 3 FACTORS, 4 CASES HAD 4 FACTORS, 1 CASE HAD 5 FACTORS, AND 1 CASE HAD 6 FACTORS. IT IS UNKNOWN AT THIS TIME WHICH AND HOW MANY OF THESE CONTRIBUTING FACTORS MAY APPLY TO THE ABOVE REPORTED EVENTS; THESE FACTORS MAY ALSO APPLY TO THOSE REPORTED BY THE MANUFACTURER THROUGH REGULATORY REPORT #3007566237-2017-02864.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492476 IMPLANTABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention