BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4424159 · Received January 15, 2015

    Report

    Report Number
    3007566237-2015-00142
    Event Type
    Injury
    Date Received
    January 15, 2015
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION AS IT WAS USED FOR PERIPHERAL NERVE STIMULATION. CONCOMITANT: PRODUCT ID 3777, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID 3777, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    GUENTCHEV, M., PREUSS, C., RINK, R., PETER, L., WOCKER, E.L., TUETTENBERG, J. TECHNICAL NOTE: TREATMENT OF SACROILIAC JOINT PAIN WITH PERIPHERAL NERVE STIMULATION. NEUROMODULATION. 2014: DOI: 10.1111/NER.12255. SUMMARY: SACROILIAC JOINT (SIJ) PAIN AFFECTS OLDER ADULTS WITH A PREVALENCE OF UP TO 20% AMONG PATIENTS WITH CHRONIC LOW BACK PAIN. WHILE PAIN MEDICATION, JOINT BLOCKS AND DENERVATION PROCEDURES ACHIEVE PAIN RELIEF IN MOST PATIENTS, SOME CASES FAIL TO IMPROVE. OUR GOAL WAS TO DETERMINE THE EFFECTIVENESS OF SIJ PERIPHERAL NERVE STIMULATION IN PATIENTS WITH SEVERE CONSERVATIVE THERAPY¿REFRACTORY SIJ PAIN. HERE WE PRESENT 12 PATIENTS WITH SEVERE CONSERVATIVE THERAPY¿REFRACTORY PAIN RECEIVING AN SIJ PERIPHERAL NERVE STIMULATION. PATIENT SATISFACTION, PAIN, AND QUALITY OF LIFEWERE EVALUATED BY MEANS OF THE INTERNATIONAL PATIENT SATISFACTION INDEX (IPSI), VISUAL ANALOG SCALE (VAS), AND OSWESTRY DISABILITY INDEX 2.0 (ODI) USING STANDARD QUESTIONNAIRES. FOR STIMULATION WE PLACED AN EIGHT-POLE PERIPHERAL NERVE ELECTRODE PARALLEL TO THE SIJ. TWO WEEKS POSTOPERATIVELY, OUR PATIENTS REPORTED AN AVERAGE ODI REDUCTION FROM 57% TO 32% AND VAS FROM 9 TO 2.1. IPSI WAS 1.1. AFTER SIX MONTHS, THE THERAPY WAS RATED AS EFFECTIVE IN SEVEN OUT OF EIGHT PATIENTS REPORTING AT THAT PERIOD. THE AVERAGE ODI WAS LOW AT 34% (P = 0.0006), WHILE THE VAS INDEX ROSE TO 3.8 (P <(><<)> 0.0001) AND IPSI TO 1.9. TWELVE MONTHS AFTER STIMULATION, SIX OUT OF SEVEN PATIENTS CONSIDERED THEIR TREATMENT A SUCCESS WITH AN AVERAGE ODI OF 21% (P <(> <<)> 0.0005), VAS 1.7 (P <(><<)> 0.0001), AND IPSI 1.3. WE CONCLUDE THAT SIJ STIMULATION IS A PROMISING THERAPEUTIC STRATEGY IN THE TREATMENT OF INTRACTABLE SIJ PAIN. FURTHER STUDIES ARE REQUIRED TO DETERMINE THE PRECISE TARGET GROUP AND LONG-TERM EFFECT OF THIS NOVEL TREATMENT METHOD. REPORTED EVENTS: ONE (B)(6) PATIENT EXPERIENCED THERAPY FAILURE AFTER THE SIX MONTH CHECKPOINT. AFTER RE-IMPLANTATION OF THE ELECTRODE, A VISUAL ANALOG SCORE (VAS) OF 0 WAS ACHIEVED AT THE 12 MONTH CHECKPOINT. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: PRIME ADVANCED IMPLANTABLE NEUROSTIMULATOR MODEL 37702 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
    35173 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37702 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention