BEUDAMED
    FDA Adverse Event Death Summary report: N

    PISCES-OCTAD

    MDR report key: 4217937 · Received October 31, 2014

    Report

    Report Number
    3007566237-2014-03188
    Event Type
    Death
    Date Received
    October 31, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE ARTICLE. THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. (B)(4).

    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 EVENTS: ONE (B)(6) MALE PATIENT EXPERIENCED A DURAL PUNCTURE DURING IMPLANTATION OF THE LEAD FOR TEST STIMULATION, CAUSING A POSTDURAL PUNCTURE HEADACHE; IT WAS NOTED THAT THE PROCEDURE WAS IMMEDIATELY STOPPED. AFTER CONSERVATIVE TREATMENT WAS STARTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THREE DAYS AFTER THE PROCEDURE, THE HEADACHE SUDDENLY INCREASED AND WITHIN MINUTES, THE PATIENT BECAME UNRESPONSIVE. THE PATIENT WAS TRANSFERRED TO THE NEAREST HOSPITAL WHERE A CT SCAN SHOWED A LARGE SUBDURAL HEMATOMA OVER THE LEFT HEMISPHERE WITH A DIAMETER OF 26MM, CAUSING A MIDLINE SHIFT OF 19.8MM. DESPITE IMMEDIATE SURGICAL EVACUATION OF THE SUBDURAL HEMATOMA, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND DIED 10 DAYS AFTER SURGERY. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: OCTAD LEAD MODEL 3898 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
    699592 PISCES-OCTAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3898 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death| H| R