BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7095445 · Received December 7, 2017

    Report

    Report Number
    3004426659-2017-00057
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL IMPLANT: SYSTEM CONSISTS OF THE RNS NEUROSTIMULATOR AND FOUR LEADS: PORT 1, DL-344, SN (B)(4), LEFT LATERAL TEMPORAL NODE. PORT 2, DL-344, SN (B)(4), LEFT MESIAL TEMPORAL POSTERIOR PERIVENTRICULAR NODE. NOT CONNECTED, DL-330, SN (B)(4), LEFT MESIAL TEMPORAL, ANTERIOR PERI NODE. NOT CONNECTED, DL-344, SN (B)(4), LEFT MESIAL TEMPORAL HIPPOCAMPUS.

    Description of Event or Problem · 1

    NEUROPACE WAS NOTIFIED ON 11/7/2017 THAT THE PATIENT HAD BEEN EXPLANTED DUE TO INFECTION. FURTHER INFORMATION PROVIDED BY THE SITE CLARIFIED THAT THE PATIENT HAD NOTICED INCREASING DRAINAGE FROM WOUND FOR 2 WEEKS PRIOR TO COMING TO THE EMERGENCY DEPARTMENT ON (B)(6) 2017. FRANK PURULENT DRAINAGE WAS EXPRESSED FROM TWO AREAS ON THE RIGHT SCALP. THE PATIENT STATED THAT HE HAD NOT SHOWERED SINCE HIS SURGERY IN (B)(6). THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2017 FOR EXPLANT OF THE RNS NEUROSTIMULATOR AND LEADS. ANTIBIOTIC TREATMENT CONSISTED OF VANCOMYCIN, NAFZIL, AND CEFAZOLIN. THE SITE DESCRIBED THE INFECTION AS A SUPERFICIAL AND DEEP INCISIONAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875741 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 23821-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R