BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 6231417 · Received January 6, 2017

    Report

    Report Number
    3007566237-2017-00069
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    August 23, 2016
    Report Date
    January 6, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: 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. CONCOMITANT MEDICAL PRODUCT6S: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WILLE, F., BREEL, JS., BAKKER, EW., HOLLMANN, MW. ALTERING CONVENTIONAL TO HIGH DENSITY SPINAL CORD STIMULATION: AN ENERGY DOSE-RESPONSE RELATIONSHIP IN NEUROPATHIC PAIN THERAPY. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2016. DOI: 10.1111/NER.12529. SUMMARY: OBJECTIVES: TO EXAMINE WHETHER CONVERTING FROM CONVENTIONAL SPINAL CORD STIMULATION (SCS) TO HIGH DENSITY (HD) SCS REDUCES NEUROPATHIC PAIN OVER A PERIOD OF 12 MONTHS IN PATIENTS WITH FAILED SCS THERAPY. METHODS: RETROSPECTIVE, OPEN LABEL, SINGLE CENTER, CONSECUTIVE CASE SERIES OF 30 NEUROPATHIC PAIN PATIENTS (FAILED BACK SURGERY SYNDROME [FBSS], COMPLEX REGIONAL PAIN SYNDROME [CRPS], AND POLYNEUROPATHY [NP]). PATIENTS WITH AN INITIAL ADEQUATE RESPONSE TO CONVENTIONAL SCS, BUT IN WHOM PAIN INCREASED OVER TIME, WERE INCLUDED (NUMERIC RATING SCALES [NRS] >6). THESE PATIENTS WERE STIMULATED WITH HD-SCS PARAMETERS AND FOLLOWED-UP FOR 12 MONTHS. WE REPORT PAIN INTENSITY, MEASURED WITH NRS, BEFORE SCS IMPLANTATION, 1 AND 3 MONTHS AFTER STARTING SCS WITH CONVENTIONAL STIMULATION, AND AFTER 1, 6, AND 12 MONTHS OF HD SCS. RESULTS: PAIN REDUCTION WITH CONVENTIONAL STIMULATION WAS INITIALLY ADEQUATE (NRS MEAN 8.6 TO 5.3 AT THREE MONTHS POSTIMPLANT) BUT INCREASED OVER TIME TO A MEAN NRS OF 7.7 AT THE TIME OF REPROGRAMMING. NRS SCORES DECREASED SIGNIFICANTLY TO 4.3 (P50.015) AFTER REPROGRAMMING FROM CONVENTIONAL SCS (30 HZ, 300 MSEC, 3.0 V) TO HD SCS (409 HZ, RANGE 130¿1000 HZ, 409 MSEC, 2.4V) IN THE PATIENTS STILL USING HD-SCS AT 12 MONTHS. IN THE NONRESPONDERS (PATIENTS WHO STOPPED HD-SCS FOR ANY REASON), 76% HAD A DIAGNOSIS OF FBSS. ALMOST HALF OF THE PATIENTS ABORTING HD-SCS PREFERRED TO FEEL PARESTHESIAS DESPITE BETTER PAIN RELIEF. THERE WAS A SIGNIFICANT DIFFERENCE BETWEEN NONRESPONDERS AND RESPONDERS REGARDING THE AMOUNT OF ELECTRICAL ENERGY DELIVERED TO THE SPINAL CORD. CONCLUSION: NEUROPATHIC PAIN SUPPRESSION IS SIGNIFICANTLY ENHANCED AFTER CONVERTING FROM FAILED CONVENTIONAL SCS TO HD SCS IN PATIENTS WITH FBSS, CRPS, AND NP OVER A MEASURED PERIOD OF 12 MONTHS. THERE APPEARS TO BE A DOSE-RELATED RESPONSE BETWEEN THE AMOUNT OF ENERGY DELIVERED TO THE SPINAL CORD AND CLINICAL EFFECT. REPORTED EVENTS: 1 PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR NEUROPATHIC PAIN HAD THE DEVICE EXPLANTED DUE TO ¿DISLOCATIONS.¿ IT WAS NOTED THAT INITIALLY PATIENTS WERE IMPLANTED WITH PRIMARY CELL DEVICES WHICH WERE LATER REPLACED WITH RECHARGEABLE DEVICES. HOWEVER NO ADDITIONAL SPECIFIC DEVICE INFORMATION WAS PROVIDED, NOR WAS IT POSSIBLE TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14264 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention