BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7176443 · Received January 9, 2018

    Report

    Report Number
    3007566237-2018-00101
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    September 20, 2017
    Report Date
    January 9, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION. MORITZ, DC., HARRINGTON, AT., SLAVIN, K., GOMEZ, C., JARRETT, OD. DEEP BRAIN STIMULATOR INFECTION BY A NOVEL RAPID GROWING MYCOBACTERIUM. ACTA NEUROCHIR (WIEN). 2017;159(11):2239-2241. DOI: 10.1007/S00701-017-3335-5.

    Description of Event or Problem · 1

    SUMMARY: DEVISE-RELATED INFECTIONS AFTER DEEP BRAIN STIMULATOR IMPLANTATION ARE NOT UNCOMMON. HOWEVER, INFECTIONS DUE TO MYCOBACTERIA HAVE NOT BEEN REPORTED IN THE MEDICAL LITERATURE. WE DESCRIBE THE FIRST REPORTED CASE OF DBS INFECTION DUE TO A NOVEL RAPIDLY GROWING MYCOBACTERIA MOST CLOSELY RESEMBLING MYCOBACTERIUM GOODII, BY RPOB GENE SEQUENCING. REPORTED EVENTS: A (B)(6) MALE WITH ESSENTIAL TREMORS UNDERWENT TWO-STAGE IMPLANTATION OF LEFT THALAMIC DEEP BRAIN STIMULATION (DBS). THREE WEEKS LATER HE DEVELOPED GENERATOR POCKET SWELLING WITH PURULENT DRAINAGE FROM THE INCISION AND MILD RIGHT RETRO-AURICULAR DISCOMFORT ALONG THE EXTENSION CABLES. THE PATIENT WAS TAKEN TO THE OPERATIVE ROOM FOR REMOVAL OF THE GENERATOR AND WASHOUT OF THE GENERATOR POCKET. THE RETRO-AURICULAR CABLE TRACK WAS ALSO EXPLORED DURING THE OPERATION. THOUGH THERE WERE NO VISIBLE SIGNS OF INFECTION IN THIS PORTION OF THE TRACK, THE CABLES WERE CUT AT THIS LEVEL AND REMOVED INFERIORLY TOWARD THE GENERATOR SITE. THERE WERE NO IMMEDIATE COMPLICATIONS POST-OPERATION, AND THE PATIENT WAS STARTED ON TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP-SMX) TO COVER THE MOST COMMON PATHOGE NS FOR DBS INFECTIONS. CULTURES FROM THE GENERATOR POCKET WERE TAKEN INTRAOPERATIVELY, AND THE INITIAL GRAM STAIN SHOWED MANY WHITE BLOOD CELLS BUT NO ORGANISMS. AFTER 48 HOURS, THE CULTURE GREW ¿GRAM-POSITIVE RODS,¿ WHICH WERE ULTIMATELY IDENTIFIED USING GENE SEQUENCING OF BACTERIUM-SPECIFIC RPOB AND 16S RIBOSOMAL RNA, AS A RAPIDLY GROWING MYCOBACTERIUM SPP., MOST CLOSELY RESEMBLING M. GOODII. THE MYCOBACTERIUM WAS SUSCEPTIBLE TO TMP-SMX, DOXYCYCLINE, LINEZOLID, CIPROFLOXACIN, MOXIFLOXACIN, AMIKACIN AND MINOCYCLINE. THUS, THE DECISION MADE WAS TO CONTINUE TMP-SMX FOR AT LEAST 6 MONTHS. DESPITE APPROPRIATE ANTIBIOTIC THERAPY, 2 MONTHS LATER THE PATIENT DEVELOPED DEHISCENCE OF HIS RETRO-AURICULAR INCISION WITH DRAINAGE FROM THE SITE. DOXYCYCLINE WAS ADDED TO HIS ANTIBIOTIC REGIMEN, AND HE WAS TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE EXTENSION CABLES AND WOUND DEBRIDEMENT WITH PRIMARY SKIN CLOSURE. CULTURES FROM THIS PROCEDURE AGAIN GREW MYCOBACTERIUM SPP., AND THE LEADS WERE LEFT IN PLACE. THE PATIENT COMPLETED THE COURSE OF ANTIBIOTICS, AND THE INFECTION RESOLVED. THE DBS SYSTEM WAS REPLACED A FEW MONTHS LATER. THE PATIENT HAS HAD NO FURTHER COMPLICATIONS OR RELAPSE OF INFECTIONS SINCE THEN. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18538 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention