BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5166110 · Received October 21, 2015

    Report

    Report Number
    3007566237-2015-03051
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    June 15, 2015
    Report Date
    September 24, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    SANDERS, R.A., MOESCHLER, S.M., GAZELKA, H.M., LAMER, T.J., WANG, Z., QU, W., HOELZER, B.C. PATIENT OUTCOMES AND SPINAL CORD STIMULATION: A RETROSPECTIVE CASE SERIES EVALUATING PATIENT SATISFACTION, PAIN SCORES, AND OPIOID REQUIREMENTS. PAIN PRACTICE : THE OFFICIAL JOURNAL OF WORLD INSTITUTE OF PAIN. 2015. DOI: 10.1111/PAPR.12340. SUMMARY: SPINAL CORD STIMULATORS (SCS) ARE USED TO TREAT VARIOUS CHRONIC PAIN STATES. ESTABLISHING PATIENT OUTCOMES IN TERMS OF PAIN CONTROL, OPIOID MEDICATION USE, AND OVERALL SATISFACTION IS VITAL IN MAINTAINING SCS¿S ROLE IN CLINICAL PRACTICE. ALL PATIENTS WHO UNDERWENT SCS IMPLANTATION BETWEEN (B)(6) 2001 AND (B)(6) 2011 AT A TERTIARY ACADEMIC PAIN MEDICINE CENTER WERE INCLUDED IF HE OR SHE UNDERWENT PERMANENT CERVICAL OR THORACOLUMBAR DORSAL COLUMN SCS IMPLANTATION AND AGE WAS 18 OR GREATER. FOR THE 199 PATIENTS WHO MET INCLUSION CRITERIA, DATA WERE COLLECTED RETROSPECTIVELY. PREIMPLANT INFORMATION INCLUDED INDICATION FOR IMPLANTATION, NUMERIC RATING SCALE (NRS) SCORE, AND DOSE IN ORAL MORPHINE EQUIVALENTS (OME). POSTIMPLANT NRS SCORE WAS RECORDED AT 6 MONTHS AND 1 YEAR. OME REQUIREMENT AND PATIENT SATISFACTION WERE DETERMINED AT 1 YEAR POSTIMPLANTATION. THIS DATA SET SHOWED AN OVERALL DECREASE IN OME REQUIREMENTS AND NRS SCORES AT BOTH 6 MONTHS AND 1 YEAR. THESE DIFFERENCES WERE STATISTICALLY SIGNIFICANT (P <(><<)> 0.01) COMPARED TO PREIMPLANTATION VALUES. ADDITIONALLY, 84.27% OF PATIENTS WERE SATISFIED WITH THEIR IMPLANTS AT 1 YEAR. PATIENT OUTCOMES WERE ANALYZED FURTHER IN RESPECT TO IMPLANT INDICATION; GROUPS INCLUDED FAILED BACK SURGERY SYNDROME (FBSS), COMPLEX REGIONAL PAIN SYNDROME (CRPS), ANGINA, AND OTHER. FOR ALL GROUPS, THERE WERE STATISTICALLY SIGNIFICANT (P <(><<)> 0.01) DECREASES IN NRS SCORES AT 6 MONTHS AND 1 YEAR. IN THE FBSS AND CRPS GROUPS, STATISTICALLY SIGNIFICANT (P <(><<)> 0.02) DECREASES IN OME USAGE EXISTED. RETROSPECTIVE REVIEW OF PATIENTS WITH SPINAL CORD STIMULATORS REVEALED OME REDUCTION AT 1 YEAR FOR THOSE PATIENTS IN THE FBSS AND CRPS GROUPS; PATIENT SATISFACTION AT 1 YEAR AND NRS SCORE REDUCTION AT 6 MONTHS AND 1 YEAR WERE STATISTICALLY SIGNIFICANT FOR ALL GROUPS. REPORTED EVENTS: 2 PATIENTS HAD THE SPINAL CORD STIMULATION (SCS) DEVICE EXPLANTED DUE TO CLINICAL CONCERNS FOR INFECTION WITHIN THE FIRST TWO MONTHS OF IMPLANT. ONE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO BATTERY FAILURE BETWEEN 6 MONTHS AND ONE YEAR AFTER IMPLANT. THIRTEEN PATIENTS UNDERWENT A REVISION OF THEIR EXISTING SPINAL CORD STIMULATION (SCS) DEVICES. TWO PATIENTS HAD THE SCS DEVICE EXPLANTED DUE TO IMPLANTABLE PULSE GENERATOR (IPG) SITE TENDERNESS WITHIN THE FIRST 6 MONTHS OF IMPLANT. ONE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO PAINFUL STIMULATION WITHIN THE FIRST 6 MONTHS OF IMPLANT. ONE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO PAINFUL STIMULATION BETWEEN 6 MONTHS AND ONE YEAR AFTER IMPLANT. TWO PATIENTS HAD THE SCS DEVICE EXPLANTED DUE TO INEFFECTIVE STIMULATION WITHIN IN THE FIRST 6 MONTHS OF IMPLANT. ONE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO INEFFECTIVE STIMULATION BETWEEN 6 MONTHS AND ONE YEAR AFTER IMPLANT. ONE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO INADEQUATE COVERAGE WITHIN THE FIRST 6 MONTHS OF IMPLANT. TWO PATIENTS HAD THE SCS DEVICE EXPLANTED DUE TO INADEQUATE COVERAGE BETWEEN 6 MONTHS AND ONE YEAR AFTER IMPLANT. TWO PATIENTS HAD THE SCS DEVICE EXPLANTED DUE TO INABILITY TO REPOSITION THE LEAD AFTER MIGRATION. IN ALL CASES, FOUR OR EIGHT-CONTACT PERCUTANEOUS LEADS WERE USED. IT WAS NOTED THERE WERE LEADS FROM MULTIPLE DIFFERENT MANUFACTURERS IN THIS ARTICLE. 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
    693973 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 00052 YR Required Intervention