BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3553813 · Received January 6, 2014

    Report

    Report Number
    3007566237-2014-00041
    Event Type
    Injury
    Date Received
    January 6, 2014
    Report Date
    December 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. PRODUCT ID: 7427V, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427V, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427V, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427V, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7427V, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3898, LOT:UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SLANGEN, R., PLUIJMS, W. A., FABER, C. G., DIRKSEN, C. D., KESSELS, A. G., VAN KLEEF, M. SUSTAINED EFFECT OF SPINAL CORD STIMULATION ON PAIN AND QUALITY OF LIFE IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY. BRITISH JOURNAL OF ANAESTHESIA. 2013;111(6):1030-1031. DOI:10.1093/BJA/AET397. SUMMARY: PAINFUL DIABETIC PERIPHERAL NEUROPATHY (PDPN) IS A COMMON COMPLICATION OF DIABETES MELLITUS (DM) AND MAY CAUSE PHYSICAL AND EMOTIONAL SUFFERING WITH SEVERE IMPACT ON QUALITY OF LIFE (QOL).1 PHARMACOLOGICAL TREATMENT OFTEN IS ONLY PARTIALLY EFFECTIVE OR UN SUCCESSFUL DUE TO UNACCEPTABLE SIDE-EFFECTS. SPINAL CORD STIMULATION (SCS) IS CONSIDERED A POSSIBLE TREATMENT MODALITY. RECENTLY, THE SHORT- AND LONG-TERM RESULTS OF SCS IN PDPN WERE REVIEWED,2 SHOWING SUFFICIENT PAIN RELIEF IN 15 OUT OF 24 PATIENTS (63%) AFTER 1 YR.3¿5 AFTER 2.5¿3 YR, THE PERCENTAGE OF PATIENTS WHO EXPERIENCED PAIN RELIEF REMAINED 63%, ALTHOUGH THE NUMBER OF PATIENTS DECREASED FROM 24 TO 19.3 6 IN VIEW OF THESE FINDINGS, WE STUDIED THE LONG TERM EFFECTIVENESS OF SCS ON PAIN AND QOL IN PATIENTS WITH PDPN. THE SHORT-TERM RESULTS OF SCS WERE REPORTED EARLIER IN A PROSPECTIVE OPEN-LABEL COHORT STUDY.7 BESIDES THE EFFECT OF SCS ON PAIN, EFFECT ON PATIENTS¿ QOL WAS INVESTIGATED. COMPLICATIONS AND ADVERSE EVENTS WERE REGISTERED. THE STUDY PROTOCOL WAS APPROVED BY THE LOCAL MEDICAL ETHICS COMMITTEE, AND ALL PATIENTS GAVE WRITTEN INFORMED CONSENT. REPORTED EVENT: 1. ONE PATIENT HAD THE SPINAL CORD STIMULATION (SCS) SYSTEM REMOVED 29 MONTHS AFTER IMPLANTATION DUE TO A LOSS OF BENEFIT. 2. ONE PATIENT HAD THE SCS SYSTEM REMOVED 34 MONTHS AFTER IMPLANTATION DUE TO A LOSS OF BENEFIT. 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
    5337 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention