BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4374278 · Received December 31, 2014

    Report

    Report Number
    3007566237-2014-03827
    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. CONCOMITANT PRODUCT: 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. 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 (B)(6) 1996 UNTIL (B)(6) 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 FOLLOWING HEMATOMA AND FISTULA, ALONG WITH PUS DRAINAGE FROM THE WOUND AND TENDERNESS OVER THE EXTENSION LEADS FOLLOWING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. IT WAS NOTED THAT A CULTURE OF THE WOUND SHOWED COAGULASE-NEGATIVE STAPHYLOCOCCI. THE PATIENT WAS TREATED WITH DICLOXACILLIN. THE PATIENT UNDERWENT THREE REVISIONS WITH DEBRIDEMENT AND GENTACOLL. 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
    861583 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention