BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4214919 · Received October 30, 2014

    Report

    Report Number
    3007566237-2014-03169
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 7, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN; PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN; PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN; PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN; PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3898, LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7472-20, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_CABLE/SNAPLID, LOT# 203844163, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4) THE MANUFACTURING REPORT NUMBER HAS BEEN UPDATED TO (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS INFECTED WITH A (B)(6), WHICH WAS CONFIRMED BY A CULTURE. THE (B)(6) WAS ATTACHED TO THE STIMULATION LEAD AND THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. IT WAS NOTED THAT THERE WERE NO OBSERVED DEVICE MALFUNCTIONS. THE REPORTER STATED THAT THE PATIENT DID NOT FULLY RECOVER DUE TO THE BASELINE CONDITION OF DIABETIC POLYNEUROPATHY, WHICH IS A SLOWLY PROGRESSIVE DISEASE.

    Description of Event or Problem · 1

    SLANGEN, R., SCHAPER, N.C., FABER, C.G., JOOSTEN, E.A., DIRKSEN, C.D., VAN DONGEN, R.T., KESSELS, A.G., VAN KLEEF, M. SPINAL CORD STIMULATION AND PAIN RELIEF IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY: A PROSPECTIVE TWO-CENTER RANDOMIZED CONTROLLED TRIAL. DIABETES CARE. 2014:PII DC_140684. DOI: 10.2337/DC14-0684 SUMMARY: PAINFUL DIABETIC PERIPHERAL NEUROPATHY (PDPN) IS A COMMON COMPLICATION OF DIABETES MELLITUS. UNFORTUNATELY, PHARMACOLOGICAL TREATMENT IS OFTEN PARTIALLY EFFECTIVE OR ACCOMPANIED BY UNACCEPTABLE SIDE EFFECTS, AND NEW TREATMENTS ARE URGENTLY NEEDED. SMALL OBSERVATIONAL STUDIES SUGGESTED THAT SPINAL CORD STIMULATION (SCS) MAY HAVE POSITIVE EFFECTS. WE PERFORMED A MULTICENTER RANDOMIZED CLINICAL TRIAL IN 36 PDPN PATIENTS WITH SEVERE LOWER LIMB PAIN, NOT RESPONDING TO CONVENTIONAL THERAPY. TWENTY-TWO PATIENTS WERE RANDOMLY ASSIGNED TO SCS IN COMBINATION WITH THE BEST MEDICAL TREATMENT (BMT) (SCS GROUP) AND 14 TO BMT ONLY (BMT GROUP). THE SCS SYSTEM WAS IMPLANTED ONLY IF TRIAL STIMULATION WAS SUCCESSFUL. TREATMENT SUCCESS WAS DEFINED AS ¿50% PAIN RELIEF DURING DAYTIME OR NIGHTTIME OR ¿(VERY) MUCH IMPROVED¿ FOR PAIN AND SLEEP ON THE PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE AT 6 MONTHS. TRIAL STIMULATION WAS SUCCESSFUL IN 77% OF THE SCS PATIENTS. TREATMENT SUCCESS WAS OBSERVED IN 59% OF THE SCS AND IN 7% OF THE BMT PATIENTS (P <(><<)> 0.01). PAIN RELIEF DURING DAYTIME AND DURING NIGHTTIME WAS REPORTED BY 41 AND 36% IN THE SCS GROUP AND 0 AND 7% IN THE BMT GROUP, RESPECTIVELY (P <(><<)> 0.05). PAIN AND SLEEP WERE ¿(VERY) MUCH IMPROVED¿ IN 55 AND 36% IN THE SCS GROUP, WHEREAS NO CHANGES WERE SEEN IN THE BMT GROUP, RESPECTIVELY (P <(><<)> 0.001 AND P <(><<)> 0.05). ONE SCS PATIENT DIED BECAUSE OF A SUBDURAL HEMATOMA. TREATMENT SUCCESS WAS SHOWN IN 59% OF PATIENTS WITH PDPN WHO WERE TREATED WITH SCS OVER A 6-MONTH PERIOD, ALTHOUGH THIS TREATMENT IS NOT WITHOUT RISKS. REPORTED EVENT: ONE PATIENT CONTRACTED AN INFECTION OF THE SPINAL CORD STIMULATION (SCS) SYSTEM 6 WEEKS AFTER THE SCS SYSTEM IMPLANTATION; THE SYSTEM WAS SUBSEQUENTLY EXPLANTED. DESPITE TREATMENT WITH ANTIBIOTICS, THE PATIENT RECOVERED SLOWLY, BUT NOT COMPLETELY. THE PATIENT ALSO DEVELOPED AN AUTONOMIC NEUROPATHY. AFTER A CONSULTATION WITH THE PATIENT, IT WAS DECIDED THAT THE SCS SYSTEM WOULD NOT BE RE-IMPLANTED. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: OCTAD LEAD MODEL 3898 AND SYNERGY VERSITREL INS MODEL 7427V OR PRIME ADVANCED INS 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
    696318 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7427V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention