BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 4374621 · Received December 31, 2014

    Report

    Report Number
    3007566237-2014-03831
    Event Type
    Injury
    Date Received
    December 31, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN; PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN; PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THRANE, J.F., SUNDE, N.A., BERGHOLT, B., ROSENDAL, F. INCREASING INFECTION RATE IN MULTIPLE IMPLANTED PULSE GENERATOR CHANGES IN MOVEMENT DISORDER PATIENTS TREATED WITH DEEP BRAIN STIMULATION. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2014;92(6):360-364. DOI: 10.1159/000365576 SUMMARY: DEEP BRAIN STIMULATION HAS BEEN PERFORMED AT THE DEPARTMENT OF NEUROSURGERY, AARHUS UNIVERSITY HOSPITAL (AUH), FOR 16 YEARS. THE RISK OF INFECTION RELATED TO IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT CONSTITUTES A WEAKNESS IN THE LONG-TERM DBS TREATMENT. THE AIM OF THIS STUDY IS TO INVESTIGATE THE ASSOCIATION BETWEEN RISK OF INFECTION AND NUMBER OF IPG REPLACEMENTS. ALL PATIENTS WHO UNDERWENT IPG REPLACEMENT AT THE AUH FROM JUNE 1996 UNTIL SEPTEMBER 2012 WERE INCLUDED IN THE STUDY, AND THEIR MEDICAL RECORDS WERE SYSTEMATICALLY REVIEWED. THE DATA WAS ANALYZED USING FISHER¿S EXACT TEST ON CONTINGENCY TABLES. 220 PROCEDURES OF IPG REPLACEMENT WERE COMPLETED ON 105 PATIENTS WHO SUFFERED FROM VARIOUS MOVEMENT DISORDERS. UP TO 5 IPG CHANGES WERE REGISTERED IN A SINGLE PATIENT. THIRTEEN PATIENTS INCURRED INFECTION REQUIRING SURGICAL INTERVENTION. TESTING FOR RISK OF INFECTION ASSOCIATED WITH NUMBER OF IPG CHANGES, THIS STUDY FOUND SIGNIFICANTLY DIFFERENT INFECTION RATES (P = 0.0052). IN THE GROUPS WITH 3 AND 4 IPG CHANGES, INFECTION RATES REACHED OVER 20%. THIS STUDY FOUND SIGNIFICANTLY DIFFERENT RATES OF INFECTION RELATED TO THE NUMBER OF IPGCHANGES. FURTHER INVESTIGATION AND RESOURCES SHOULD BE DIRECTED TOWARDS IMPROVING THE LIFESPAN OF IPGS. REPORTED EVENTS: ONE (B)(6) FEMALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED AN INFECTION WITH PUS DRAINAGE FROM THE WOUND AND REDNESS OVER AND ALONG THE EXTENSION LEADS FIVE WEEKS AFTER AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THIRTY-SEVEN DAYS AFTER THE REPLACEMENT SURGERY THE PATIENT HAD THE INS AND EXTENSION LEADS EXPLANTED AND DISCONTINUED TREATMENT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861401 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention