BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5261291 · Received December 2, 2015

    Report

    Report Number
    3007566237-2015-03576
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    October 6, 2015
    Report Date
    January 25, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    LEVI, V., CARRABBA, G., RAMPINI, P., LOCATELLI, M. "SHORT TERM SURGICAL COMPLICATIONS AFTER SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE: DOES OLD AGE MATTER?" BMC GERIATRICS. 2015;15(1):116. DOI 10.1186/S12877-015-0112-2. SUMMARY: PATIENTS AGED 65 YEARS AND OLDER ARE NOT TRADITIONALLY CONSIDERED OPTIMAL CANDIDATES FOR SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS), MAINLY FOR THEIR PRESUMED INCREASED INCIDENCE OF SURGICAL COMPLICATIONS. THE AIM OF THIS STUDY WAS TO ASSESS STN-DBS SURGERY SAFETY IN RELATION TO AGE. A TOTAL OF 107 CONSECUTIVE PATIENTS UNDERGOING BILATERAL STN-DBS AT OUR INSTITUTION BETWEEN 2002 AND 2014 WERE RETROSPECTIVELY STRATIFIED ACCORDING TO AGE IN TWO GROUPS (YOUNG GROUP <(><<)> 65 YEARS OLD; ELDERLY GROUP = 65 YEARS OLD). RATE OF SHORT-TERM SURGICAL COMPLICATIONS (WITHIN 90 DAYS) WAS REVIEWED AND COMPARED BETWEEN THE TWO GROUPS. PRE-OPERATIVE BASELINE DATA WERE COMPARABLE BETWEEN THE TWO GROUPS. THE 90-DAYS POST-OPERATIVE MORTALITY RATE WAS 0%. OVERALL INCIDENCE OF COMPLICATIONS RELATED TO SURGERY WAS 6 ,54%. IN THE ELDERLY GROUP WE OBSERVED 3 POST-OPERATIVE INTRA-CEREBRAL HAEMATOMAS (7,89%), 1 REQUIRING URGENT SURGICAL EVACUATION. IN THE YOUNG GROUP WE OBSERVED 2 POST-OPERATIVE ASYMPTOMATIC INTRA-CEREBRAL HAEMATOMAS (2,89%) AND 2 WOUND INFECTIONS (2,89%), 1 REQUIRING SYSTEM REMOVAL. NO OTHERS SURGICAL COMPLICATIONS WERE NOTICED IN BOTH GROUPS. CHRONOLOGICAL AGE = 65 YEARS OLD SHOULD NOT BE CONSIDERED ALONE AS EXCLUSION CRITERIA TO STN-DBS SURGERY. REPORTED EVENTS: 1 MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE EXPERIENCED A WOUND INFECTION AND REQUIRED SYSTEM REMOVAL AS A RESULT. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: IMPLANTABLE NEUROSTIMULATOR KINETRA OR ACTIVA PC FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FULLY RECOVERED FROM THE INFECTION, BUT WAS NO LONGER IMPLANTED. THE CAUSE OF THE ADVERSE EVENT WAS A SKIN INFECTION. IT WAS NOTED THAT THERE WERE NO DIAGNOSTICS PERFORMED AND IT WAS NOT POSSIBLE TO IDENTIFY SERIAL/LOT NUMBERS OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790732 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention