BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4130402 · Received September 30, 2014

    Report

    Report Number
    3007566237-2014-02787
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. CONCOMITANT MEDICAL PRODUCTS: 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_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    BJERKNES, S., SKOGSEID, I.M., SAEHLE, T., DIETRICHS, E., TOFT, M. SURGICAL SITE INFECTIONS AFTER DEEP BRAIN STIMULATION SURGERY: FREQUENCY, CHARACTERISTICS AND MANAGEMENT IN A 10-YEAR PERIOD. PLOS ONE. 2014;9(8):E105288. DOI:10.1371/JOURNAL.PONE.0105288. SUMMARY: DEEP BRAIN STIMULATION (DBS) IMPLANT INFECTION IS A FEARED COMPLICATION, AS IT IS DIFFICULT TO MANAGE AND LEADS TO INCREASED PATIENT MORBIDITY. WE WANTED TO ASSESS THE FREQUENCY AND POSSIBLE RISK FACTORS OF DBS RELATED INFECTIONS AT OUR CENTRE. IN THE PURPOSE OF EVALUATING TREATMENT OPTIONS, WE ALSO ANALYZED TREATMENT, AND THE CLINICAL AND MICROBIOLOGICAL CHARACTERISTICS OF THE INFECTIONS. ELECTRONIC MEDICAL RECORDS OF ALL PATIENTS UNDERGOING DBS SURGERY AT OUR CENTRE, FROM 2001 THROUGH 2010, WERE RETROSPECTIVELY REVIEWED. OF THE 588 PROCEDURES PERFORMED 33 (5.6%) LED TO AN INFECTION. SOME PATIENTS UNDERWENT SEVERAL PROCEDURES, THUS 32 OUT OF TOTALLY 368 PATIENTS (8.7%), AND 19 OUT OF 285 PATIENTS (6.7%) WHO RECEIVED PRIMARY LEAD IMPLANTATION, DEVELOPED AN INFECTION. MOST INFECTIONS (52%) DEVELOPED WITHIN THE FIRST MONTH AND 79% WITHIN THREE MONTHS. IN THE MAJORITY OF THE INFECTIONS (79%) HARDWARE REMOVAL WAS PERFORMED. STAPHYLOCOCCUS AUREUS INFECTIONS WERE THE MOST FREQUENT (36%), AND MORE LIKELY TO HAVE EARLIER ONSET, PUS FORMATION, A MORE AGGRESSIVE DEVELOPMENT AND LEAD TO HARDWARE REMOVAL. NO RISK FACTORS WERE IDENTIFIED. OUR RESULTS INDICATE THAT INFECTIONS WITH MORE SEVERE SYMPTOMS AND GROWTH OF STAPHYLOCOCCUS AUREUS SHOULD BE TREATED WITH LOCAL HARDWARE REMOVAL AND ANTIBIOTIC THERAPY. IN OTHER INFECTIONS, AN INITIAL TRIAL OF ANTIBIOTIC TREATMENT COULD BE CONSIDERED. NEW KNOWLEDGE ABOUT THE MICROBIOLOGY OF DBS RELATED INFECTIONS MAY LEAD TO MORE EFFECTIVE ANTIMICROBIAL TREATMENT. REPORTED EVENTS: 2 PATIENTS DEVELOPED INFECTIONS THAT OCCURRED LATER THAN ONE YEAR AFTER SURGERY. THESE INFECTIONS DEVELOPED IN THE SECOND YEAR AFTER SURGERY AND WERE BOTH DUE TO CHRONIC EROSION OF THE SKIN. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: EITHER A KINETRA (MODEL # 7428), SOLETRA (MODEL # 7426) , OR ACTIVA (MODEL # 37601, 37612, 37602, OR 37603) DEVICE WAS IMPLANTED. 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
    608846 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention