BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULOATOR

    MDR report key: 8675737 · Received June 6, 2019

    Report

    Report Number
    3007566237-2019-01244
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    January 1, 2018
    Report Date
    June 6, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: YANG J, CHOI Y, PARK J, JEONG J, LEE B, LEE K, LEE J, CHOI R. REVERSIBLE HORNER'S SYNDROME AFTER CERVICAL SPINAL CORD STIMULATOR IMPLANTATION IN A PATIENT WITH COMPLEX REGIONAL PAIN SYNDROME. JOURNAL OF PAIN RESEARCH. 2018;11:3019-3023. DOI: 1 0.2147/JPR.S182345. DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION YEAR, AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. DESCRIPTION OF PROBLEM OR EVENT: 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNKNOWN VECTRIS LEAD, LOT #: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: THE AUTHORS REPORTED SUCCESSFULLY PERFORMING CERVICAL SPINAL CORD STIMULATOR (SCS) SURGERY IN A (B)(6) MAN WITH COMPLEX REGIONAL PAIN SYNDROME TO CONTROL INTRACTABLE PAIN. THE SCS TRIAL WAS PERFORMED TWICE TO ADJUST THE SCS COVERAGE REGION. AFTER PERMANENT IMPLANTATION SURGERY, THE PATIENT DEVELOPED HORNER¿S SYNDROME WHEN THE REGION NEAR THE C4 SPINAL DORSAL ROOT WAS STIMULATED. HOWEVER, HORNER¿S SYNDROME DISAPPEARED AFTER CHANGING THE STIMULATION LEADS. THE AUTHORS NOTED THAT THE CASE REPORT SUGGESTED THAT CERVICAL SCS CAN BE ASSOCIATED WITH SUPERIOR CERVICAL GANGLION STIMULATION. REPORTED EVENT: IT WAS REPORTED THAT A (B)(6) MAN UNDERWENT SURGICAL INTERVENTION FOR RIGHT RADIAL STYLOID FRACTURE 6 YEARS PRIOR TO REPORT. SEVERAL MONTHS AFTER THE OPERATION, THE PATIENT COMPLAINED OF INTENSE AND SEVERE BURNING PAIN (VISUAL ANALOG SCALE: 8/10), EDEMA, REDUCED STRENGTH, COLD ALLODYNIA, AND HYPERALGESIA IN THE RIGHT FOREARM. HE WAS DIAGNOSED WITH CRPS TYPE I BY A PAIN MANAGEMENT SPECIALIST. HE UNDERWENT A SERIES OF RIGHT STELLATE GANGLION BLOCKS, WHICH PROVIDED MINIMAL PAIN RELIEF ONLY FOR THE DURATION OF THE LOCAL ANESTHETICS. THE PATIENT WAS GIVEN VARIOUS MEDICATIONS SUCH AS CARBAMAZEPINE, PREGABALIN, GABAPENTIN, OXYCODONE, AND FENTANYL TO MANAGE THE PAIN, BUT NONE OF MEDICINES PROVIDED COMPLETE PAIN RELIEF. FURTHERMORE, TREATMENT BY A PHYSICAL THERAPIST AND PAIN PSYCHOLOGIST WAS ALSO NOT EFFECTIVE. AFTER STRUGGLING WITH CRPS FOR 6 YEARS, HE WAS REFERRED TO A PAIN MANAGEMENT CLINIC FOR SCS INSERTION. THE RESULTS OF PREOPERATIVE LABORATORY TESTS, CHEST RADIOGRAPHY, AND ELECTROCARDIOGRAM WERE NORMAL. A PERCUTANEOUS LEAD TRIAL WAS PERFORMED; THE ELECTRODE LEAD WAS INSERTED INTO THE CERVICAL EPIDURAL SPACE BY USING THE LOSS OF RESISTANCE TECHNIQUE. THE UPPER TIP OF THE ELECTRODE WAS POSITIONED TO REACH THE TOP OF THE C3 BODY UNDER CONTINUOUS FLUOROSCOPY. THE LEAD OF SPINAL NEUROSTIMULATOR WAS LOCATED AT THE MIDLINE OF THE C3 BODY. IN THE TESTING OF ELECTRODES, COMPLETE COVERAGE FOR THE RIGHT ARM WAS ACHIEVED WITH THE STIMULATION OF THE SECOND AND THIRD ELECTRODES. AFTER COMPLETING THE FIRST STIMULATION TRIAL, THE PATIENT¿S PAIN INTENSITY IMPROVED FROM 8 TO 4 ON THE VISUAL ANALOG SCALE. IN ADDITION TO THE PAIN RELIEF, HE COULD TOUCH COLD WATER WITHOUT ALLODYNIA. ON POSTOPERATIVE DAY (POD) 1, HIS RIGHT ARM PAIN AGGRAVATED AND PARESTHESIA FROM SPINAL CORD STIMULATION WAS NOW EXPERIENCED IN THE LEFT INSTEAD OF RIGHT ARM. THE AUTHORS TRIED STIMULATION OF VARIOUS ELECTRODES TO RELIEVE THE PATIENT OF HIS LEFT-ARM PARESTHESIA, BUT TO NO AVAIL. ON CERVICAL RADIOGRAPHY, IT WAS DIFFICULT TO FIND THE CHANGE IN THE LEAD LOCATION. AT POD 3, A SECOND SCS TRIAL WAS PLANNED TO RELOCATE THE LEAD. THE PERMANENT SCS LEAD WAS LOCATED TO THE RIGHT SIDE OF THE C3 BODY TO ENSURE RIGHT ARM STIMULATION. THE PERMANENT LEAD WAS CONNECTED TO AN EXTERNAL NEUROSTIMULATOR (ENS) USING AN EXTENSION CABLE. AFTER THE SECOND STIMULATION TRIAL, THE PARESTHESIA FROM SPINAL CORD STIMULATION WAS ONLY ACHIEVED AT THE RIGHT ARM OF THE PATIENT FROM THE STIMULATION OF THE SECOND AND THIRD LEAD. AT POD 4, HE COMPLAINED OF MINOR INABILITY TO FOCUS ON NEARBY OBJECTS, BUT THERE WAS NO SPECIFIC PROBLEM OBSERVED IN ANY PHYSICAL AND NEUROLOGICAL EXAMINATION. FURTHER EVALUATION FOR MYOPIA WAS POSTPONED AFTER SCS IMPLANTATION. THE EFFECTIVENESS FOR PAIN RELIEF BETWEEN THE FIRST AND SECOND TRIAL WAS SIMILAR. ON POD 6, A SURGERY FOR PERMANENT IMPLANTATION WAS PERFORMED UNDER LOCAL ANESTHESIA. THE EXTENSION CABLE WAS REMOVED, AND A PERMANENT LEAD WAS CONNECTED TO AN IMPLANTABLE NEUROSTIMULATOR (INS) BURIED UNDER THE SKIN OF THE RIGHT SUBCLAVICULAR AREA. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470070 EXTERNAL NEUROSTIMULOATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention