BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 5963549 · Received September 20, 2016

    Report

    Report Number
    3004426659-2016-00023
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    November 29, 2017
    Report Date
    January 30, 2018
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE PATIENTS 5TH NEUROSTIMULATOR FOR 12/22/2015 PATIENT HAD INCISION DEHISCENCE FROM THE REPLACEMENT PERFORMED ON (B)(6) 2015. THE FERRULE WAS EXPLANTED AND A NEW FERRULE WAS RE-SEATED DEEPER IN SKULL BONE. PLASTIC SURGEON CLOSED INCISION USING 2 LAYERS OF INTERRUPTED SUTURES. REFERENCE 3004426659-2015-00034, (B)(4). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2017 THE PATIENT UNDERWENT EXPLANT OF THE RNS NEUROSTIMULATOR AND ONE DEPTH LEAD (THE OTHER LEAD WAS LEFT IMPLANTED) AT (B)(6). A SKIN GRAFT FROM THE THIGH AND SCALP WERE USED TO CLOSE THE OPEN AREA IN THE SCALP. NO POSTOPERATIVE COMPLICATIONS WERE REPORTED. WOUND CULTURES WERE TAKEN BY INFECTIOUS DISEASE; HOWEVER THE RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT WAS DISCHARGED WITH TWO ANTIBIOTICS ON (B)(6) 2017. A FOLLOW-UP APPOINTMENT WITH THE PLASTIC SURGEON WAS SCHEDULED FOR (B)(6) 2017. THE SITE REPORTS THAT THE CAUSE OF THE CONTINUED PROBLEM WITH DEHISCENCE IS DUE TO THE PATIENT'S THIN SKIN AND PROBABLE INFECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CULTURES TAKEN AT SURGERY ON (B)(6) 2017 - RESULTS PRESENTED. A FOLLOW-UP APPOINTMENT WAS CONDUCTED ON (B)(6) 2017 AT WHICH THE GRAFT WAS FELT TO BE SETTLING IN. ANTIBIOTICS WERE CONTINUED PER INFECTIOUS DISEASE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE PATIENT SYNCHRONIZED THEIR REMOTE MONITOR RESULTING IN NEUROPACE BECOMING AWARE THAT THE PATIENT'S NEUROSTIMULATOR HAD EXPERIENCED A DC LEAK RESET ON (B)(6) 2017. SINCE THE RESET HAD NOT BEEN CLEARED, THE PATIENT HAD NOT BEEN RECEIVING RESPONSIVE STIMULATION SINCE THAT DATE. UPON COMMUNICATION WITH THE TREATING CENTER ON (B)(6) 2017, IT WAS DETERMINED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN THE AREA OF THE NEUROSTIMULATOR ON (B)(6) 2017 TO IMPLANT A TISSUE EXPANDER AS PART OF THE TREATMENT STRATEGY FOR THE ONGOING WOUND DEHISCENCE; HOWEVER THE PROCEDURE WAS UNSUCCESSFUL AS THE EXPANDER WAS TOO LARGE AND COULD NOT BE PLACED. THE PATIENT WAS SUBSEQUENTLY PROVIDED A REFERRAL TO AN OUTSIDE INSTITUTION FOR A PLASTIC SURGERY CONSULT. THE SURGICAL PROCEDURE RESULTED IN THE DC LEAK RESET REPORTED BY THE NEUROSTIMULATOR. ON (B)(6) 217, THE TREATING CENTER REPORTED THAT THE PATIENT DECIDED TO LEAVE THE NEUROSTIMULATOR OFF AS IT WILL BE EXPLANTED SOON. THE PATIENT WILL BE GOING TO (B)(6) TO HAVE THE NEUROSTIMULATOR EXPLANTED AND PLASTIC SURGERY PERFORMED TO AID IN WOUND HEALING. ADDITIONAL INFORMATION PROVIDED BY THE SITE: ON (B)(6) 2017 - SUBJECT CALLED WITH UPDATED INFORMATION. AREA OF DEHISCENCE AT STIMULATOR IMPLANT SITE ON SCALP CONTINUES TO HAVE AN OPEN AREA ACCORDING TO SUBJECT. SHE HAS AN UPCOMING APPOINTMENT WITH NEUROSURGEON FOR RE-EVALUATION. ON (B)(6) 2017 SHE SAW NEUROSURGEON AND PLASTIC SURGEON. RECOMMENDATION FOR SURGERY, IMPLANTING A TISSUE EXPANDER TO CLOSE THE DEHISCED SITE. WOUND CULTURE BY NEUROSURGEON WAS NEGATIVE FOR INFECTION.

    Description of Event or Problem · 1

    DEHISCENCE AT NEUROSTIMULATOR SITE, PATIENT NOTED "OOZING" FROM HER NEUROSTIMULATOR SITE ON (B)(6) 2016. SHE CONTACTED PLASTIC SURGEON WHO EVALUATED HER THAT DAY. THE PLASTIC SURGEON REFERRED HER TO NEUROSURGEON WHO EVALUATED HER ON (B)(6) 2016. PLAN IS TO MONITOR SITE FOR FURTHER CHANGES WITH NO PLANNED SURGICAL INTERVENTION. NO ANTIBIOTICS WERE PRESCRIBED. THERE IS NO INDICATION OF PRODUCT FAILURE. THE RNS SYSTEM REMAINS PROGRAMMED FOR DETECTION AND THERAPY.

    Description of Event or Problem · 1

    AS OF 11/29/2017 NEW INFORMATION BECAME AVAILABLE TO NEUROPACE, INC.

    Description of Event or Problem · 1

    AS OF 01/02/2018 NEW INFORMATION BECAME AVAILABLE TO NEUROPACE, INC.

    Description of Event or Problem · 1

    AS OF 8/7/2017 NEW INFORMATION BECAME AVAILABLE REGARDING THE PATIENT'S SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615433 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 20655-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R