BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3024349 · Received March 27, 2013

    Report

    Report Number
    3007566237-2013-00910
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON 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. CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_ UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PEPPER, J., ZRINZO, L., MIRZA, B., FOLTYNIE, T., LIMOUSIN, P., HARIZ, M. THE RISK OF HARDWARE INFECTION IN DEEP BRAIN STIMULATION SURGERY IS GREATER AT IMPULSE GENERATOR REPLACEMENT THAN AT THE PRIMARY PROCEDURE. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2013;91(1):56-65. DOI: 10.1159/000343202. SUMMARY: INFECTION OF IMPLANTED HARDWARE AFTER DEEP BRAIN STIMULATION (DBS) HAS A SIGNIFICANT IMPACT ON PATIENT MORBIDITY. WE EXAMINED ALL PATIENTS WHO UNDERWENT DBS PROCEDURES OVER THE LAST 9 YEARS IN OUR CENTRE TO ASSESS THE INFECTION RATE AND POSSIBLE FACTORS RELATED TO SURGERY THAT MAY PREDISPOSE TO INFECTION. SURGICAL REPORTS AND CLINICAL NOTES WERE REVIEWED IN 273 CONSECUTIVE PATIENTS WHO UNDERWENT A TOTAL OF 519 DBS-RELATED PROCEDURES IN OUR INSTITUTE BETWEEN NOVEMBER 2002 AND SEPTEMBER 2011. SIXTEEN SEPARATE HARDWARE-RELATED INFECTIONS OCCURRED IN 11 PATIENTS. INFECTIONS OCCURRED IN 3% OF ALL PROCEDURES AND 4% OF ALL PATIENTS. THE INFECTION RATE AFTER IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT SURGERY WAS MORE THAN THREE TIMES HIGHER THAN AFTER DE NOVO DBS SURGERY. IN ADDITION, MALE PATIENTS WERE MORE LIKELY TO DEVELOP DEVICE-RELATED INFECTIONS. IT IS UNCLEAR WHY INFECTION RATES SHOULD BE MORE THAN THREE TIMES HIGHER AFTER IPG REPLACEMENT SURGERY THAN AFTER THE DE NOVO PROCEDURE. THE FORMER ISA SHORTER AND SIMPLER PROCEDURE TO CONDUCT. PERHAPS THE USE OF BETTER ANTIMICROBIAL PROTECTION AND RECHARGEABLE BATTERIES MAY BE USEFUL STRATEGIES TO REDUCE INFECTIONS FOLLOWING IPG REVISION SURGERY. REPORTED EVENT: A 63 YEAR OLD MALE IMPLANTED FOR DYSTONIA EXPERIENCED SUPPURATIVE INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE 3 DAYS AFTER IMPLANT. COAGULASE-NEGATIVE STAPHYLOCOCCUS WAS CULTURED. THE INS WAS REMOVED. TWO MONTHS LATER THE PATIENT EXPERIENCED EROSION OF THE CABLE THROUGH THE SKIN AND THE CABLE WAS ALSO REMOVED. A PURULENT SPOT WAS FOUND AROUND THE LEFT FRONTAL INCISION AT THE ELECTRODE SITE 4 MONTHS AFTER IMPLANT AND THE ELECTRODE WAS ALSO REMOVED. 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
    125297 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention