BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8958348 · Received September 3, 2019

    Report

    Report Number
    3007566237-2019-01882
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    July 5, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NARVAEZ-MARTINEZ, Y., ROLDAN RAMOS, P., ALEXANDER HOYOS, J., CULEBRAS, D., COMPTA, Y., CAMARA, A., MUNOZ, E., MARTI, M.J., VALLDEORIOLA, F., RUMIA, J. SINGLE-CENTER COMPLICATION ANALYSIS ASSOCIATED WITH SURGICAL REPLACEMENT OF IMPLANTABLE PULSE GENERATORS IN DEEP BRAIN STIMULATION. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2019. DOI: 10.1159/000500210. THIS VALUE IS THE MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. (PMA): P960009 (MHY) AND H020007 (MRU) BOTH APPLY AS PATIENTS WERE IMPLANTED WITH PARKINSON'S AND DYSTONIA, ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE WHICH PATIENTS EXPERIENCED WHICH EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI#: ASKU; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: INTERNAL PULSE GENERATOR (IPG) REPLACEMENT IS CONSIDERED A RELATIVELY MINOR SURGERY BUT EXPOSES THE DEEP BRAIN STIMULATION SYSTEM TO THE RISK OF INFECTIOUS AND MECHANICAL ADVERSE EVENTS. THE AUTHORS RETROSPECTIVELY REVIEWED COMPLICATIONS ASSOCIATED WITH IPG REPLACEMENT SURGERY IN THE AUTHORS' CENTER AND REVIEWED THE MOST RELEVANT PUBLICATIONS ON THE ISSUE. A RETROSPECTIVE ANALYSIS OF ALL THE IPG REPLACEMENTS PERFORMED IN THE AUTHORS' CENTER FROM JANUARY 2003 UNTIL MARCH 2018 WAS PERFORMED. A LOGISTIC REGRESSION MODEL WAS USED TO ANALYZE THE RISK FACTORS ASSOCIATED WITH IPG INFECTIONS AT THE AUTHORS' CENTER. A TOTAL OF 171 IPG REPLACEMENTS IN 93 PATIENTS WERE ANALYZED. THE OVERALL RATE OF REPLACEMENT COMPLICATIONS WAS 8.8%, WHEREAS THE RATE OF INFECTION WAS 5.8%. IPG REMOVAL WAS REQUIRED IN 8 OUT OF 10 INFECTED CASES. AN INCREASED RISK OF INFECTION WAS FOUND IN PATIENTS WITH SUBCUTANEOUS THORACIC PLACEMENT OF THE IPG (OR 5.3, P = 0.016). THE MOST COMMONLY ISOLATED GERM WAS STAPHYLOCOCCUS COAGULASE NEGATIVE (60%). THE AUTHORS FOUND A NON-SIGNIFICANT TREND TOWARDS INCREASED RISK OF INFECTION IN PATIENTS WITH MORE THAN 3 REPLACEMENTS (P = 0.07). INFECTION IS THE MOST FREQUENT COMPLICATION RELATED TO IPG REPLACEMENT. STAPHYLOCOCCUS COAGULASE NEGATIVE IS THE MOST COMMONLY ISOLATED BACTERIA CAUSING THE INFECTION. ACCORDING TO THE AUTHORS' RESULTS, THE SUBCUTANEOUS THORACIC PLACEMENT REPRESENTS A GREATER RISK OF INFECTION COMPARED TO SUBCUTANEOUS ABDOMINAL PLACEMENT. REPORTED EVENTS: TEN PATIENTS EXPERIENCED INFECTION RELATED TO INS REPLACEMENT. NINE OF THESE TEN TESTED POSITIVE FOR STAPHYLOCOCCUS (STAPHYLOCOCCUS AUREUS: 3 CASES, STAPHYLOCOCCUS COAGULASE NEGATIVE: 6 CASES). THREE OF THE TEN DEVELOPED INFECTION SECONDARY TO SKIN ULCERATION, EVEN THOUGH THE BATTERY WAS RELOCATED ON THE CONTRALATERAL SIDE AND THEY RECEIVED ANTIBIOTIC THERAPY FOR 2 WEEKS. ONE OF THESE TEN REQUIRED WHOLE DBS SYSTEM REMOVAL BECAUSE INFECTION EXTENDED ALONG THE EXTENSION WIRES. TWO PATIENTS EXPERIENCED LEAD FRACTURE THAT PRESENTED IN THE SAME SURGERY AS INS REPLACEMENT AND REQUIRED THE IMPLANTATION OF NEW EXTENSION WIRES. THE ARTICLE INDICATES THAT PATIENTS WITH REPORTED COMPLICATIONS WERE IMPLANTED FOR DYSTONIA AND PARKINSON'S DISEASE ALTHOUGH SPECIFIC PATIENTS COULDN'T BE IDENTIFIED IN THE ARTICLE. THE FOLLOWING DEVICE SPECIFICS WERE IDENTIFIED IN THE LITERATURE ARTICLE: INS MODELS 7428, 7426, 37601, 37612.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748559 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention