BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4133644 · Received October 1, 2014

    Report

    Report Number
    3004426659-2014-00008
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    December 18, 2014
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT TO BE RETURNED, PRODUCT REMAINS IMPLANTED. NO REPORT OF PRODUCT MALFUNCTION. PRODUCT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) 2014 - PATIENT WAS SEEN BY INFECTIOUS DISEASE PHYSICIAN. THERE WAS AN OBSERVED IMPROVEMENT WITH THE INFECTION SITE IT WAS DECIDED TO CONTINUE WITH THE FOLLOWING EMPIRIC ANTIBIOTIC THERAPY. 100MG DOXYCYCLINE 2X A DAY, 600MG RIFAMPIN 1X A DAY. (B)(6) 2014 - PATIENT FOLLOWED UP WITH INFECTIOUS DISEASE PHYSICIAN. PATIENT STATED FOR THE PAST WEEK THERE WAS INCREASE IN DRAINAGE FROM THE SUPERIOR WOUND. THE PLAN AFTER THE APPOINTMENT WAS TO REMOVE THE IMPLANT TO CURE THE INFECTION. PATIENT WAS TOLD THE FOLLOWING PLAN FOR MEDS. CONTINUE DOXYCYCLINE UNTIL 7 DAYS PRIOR TO SURGERY, RIFAMPIN WAS STOPPED. (B)(6) 2014 - (NOT SURE OF THE SPECIFIC DATE) - PATIENT ALSO MET WITH DR (B)(6) WHERE IT WAS DECIDED TO REMOVE THE IMPLANT ON (B)(6) 2014. (B)(6) 2014 - PATIENT WAS ADMITTED TO THE HOSPITAL, PATIENT DID NOT STOP TAKING DOXYCYCLINE. (B)(6) 2014 - RNS SYSTEM SIMULATOR AND LEADS WERE REMOVED. THE FOLLOWING MEDICATION PLAN WAS FOLLOWED: 1 DOSE OF DAPTOMYCIN 600MG IV PRIOR TO DISCHARGE AND CONTINUE ON IT AT HOME VIA HHN; STOP CEFAZOLIN UNTIL MONDAY DEC 8 IF NO NEW CULTURE DATA; RIFAMPIN 600MG ORAL 1X A DAY FOR 2 WEEKS TILL (B)(6). PATIENT WAS DISCHARGED ON (B)(6) 2014 AFTER SURGERY. LABS: SOURCE: EXPLANTED NEUROSTIMULATOR; GRAM STAIN: NO POLYS, NO ORGANISMS SEEN; CULTURE: STAPHYLOCOCCUS AUREUS; ORGANISM REMARK: BASED ON STAPHYLOCOCCUS SUSCEPTIBILITY TO OXACILLIN AND RESISTANCE TO PENICILLIN, THIS ISOLATE WOULD BE SUSCEPTIBLE TO: DICLOXACILLIN OR OXACILLIN/NAFCILLIN AMOXICILLIN-CLAVULANATE OR AMPICILLIN-SULBACTAM CEFADROXIL, CEPHALEXIN, CEFAZOLIN, CEFACLOR, OR CEFUROXIME. (B)(6) 2014 - ANTIBIOTICS WERE CHANGED TO THE FOLLOWING: CHANGED TO CEFAZOLIN 3GM IV Q8HR INSTEAD OF DAPTOMYCIN. PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    FOLLOW-UP REPORT #1.

    Description of Event or Problem · 1

    (B)(6) 2014: PATIENT IMPLANTED WITH NEUROPACE NEUROSTIMULATOR (RNS-300-M-K) AND (2) NEUROPACE CORTICAL STRIP LEADS (CL-325-10-K) PLACED OVER THE LEFT PARIETAL REGION. (B)(6) 2014: PATIENT RETURNED TO CLINIC FOR ROUTINE RNS SYSTEM APPOINTMENT AND STATED THAT THEIR INCISION HAD OPENED IN TWO PLACES AND WAS DRAINING. NEUROSURGEON PLACED THE PATIENT ON KEFLEX FOR TWO WEEKS. (B)(6) 2014: (B)(6) MEDICAL AFFAIRS HAD CONVERSATION WITH NEUROSURGEON REGARDING THE INFECTION. NEUROSURGEON STATED THAT THE INFECTION APPEARS TO BE A SOFT TISSUE INFECTION FROM THE PATIENT "PICKING" AT THE INCISION. NEUROSURGEON STATED THAT HE WILL CONTINUE TO EVALUATE THE INFECTION AND MAKE A DECISION REGARDING EXPLANTING AFTER TWO WEEKS OF ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612923 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other