BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMACORE-S UNIT

    MDR report key: 8002406 · Received October 24, 2018

    Report

    Report Number
    3009060963-2018-00001
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ELECTROCORE, INC.
    Product Code
    PKR
    UDI-DI
    00815203020010
    PMA / PMN Number
    K171306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER HAS TRIED MULTIPLE TIMES TO CONTACT PATIENT TO GATHER MORE INFORMATION, NO RESPONSE FROM PATIENT. MANUFACTURER HAS CONTACTED PATIENT'S DR'S OFFICE FOR MORE INFORMATION, THEY WILL NOT PROVIDE DUE TO HIPAA. ORIGINALLY SUBMITTED AS A 5 DAY REPORTABLE. FDA SENT RESPONSE SINCE THERE IS NO REMEDIAL ACTION LISTED, SHOULD IT BE 5 DAY? WE ARE MODIFYING TO A 30 DAY AS THERE WAS NO REMEDIAL ACTION. HAVE ATTEMPTED MULTIPLE REQUESTS TO PATIENT AND DR FOR FOLLOW-UP, SO FAR NO RESPONSES. PATIENT WENT TO ER AND WAS RELEASED WITH VALIUM. AT THIS TIME, WE DO NOT THINK THERE WAS A STROKE AS PATIENT WAS DISCHARGED. WE DO NOT FEEL THIS WAS DEVICE RELATED BUT, DUE TO NO FURTHER INFORMATION AT THIS TIME, WE ARE SUBMITTING AS A REPORTABLE MDR.

    Additional Manufacturer Narrative · 0

    MANUFACTURER HAS TRIED MULTIPLE TIMES TO CONTACT PATIENT TO GATHER MORE INFORMATION, NO RESPONSE FROM PATIENT. MANUFACTURER HAS CONTACTED PATIENT'S DR'S OFFICE FOR MORE INFORMATION, THEY WILL NOT PROVIDE DUE TO HIPAA. ORIGINALLY SUBMITTED AS A 5 DAY REPORTABLE. FDA SENT RESPONSE SINCE THERE IS NO REMEDIAL ACTION LISTED, SHOULD IT BE 5 DAY? WE ARE MODIFYING TO A 30 DAY AS THERE WAS NO REMEDIAL ACTION. HAVE ATTEMPTED MULTIPLE REQUESTS TO PATIENT AND DR FOR FOLLOW-UP, SO FAR NO RESPONSES. PATIENT WENT TO ER AND WAS RELEASED WITH VALIUM. AT THIS TIME, WE DO NOT THINK THERE WAS A STROKE AS PATIENT WAS DISCHARGED. WE DO NOT FEEL THIS WAS DEVICE RELATED BUT, DUE TO NO FURTHER INFORMATION AT THIS TIME, WE ARE SUBMITTING AS A REPORTABLE MDR. THE ELECTROCORE AE TEAM CONSISTING OF THE QA VP AND DIRECTOR, VP/CHIEF MEDICAL OFFICER, CLINICAL MANAGER AND ASSOCIATE DIRECTOR/BSN/RN, ALONG WITH VP MEDICAL AFFAIRS, MET TO EVALUATE THE PATIENTS PHYSICIAN DIAGNOSIS WHICH WAS OBTAINED. THE PHYSICIAN SAID SHE HAD SIMILAR SYMPTOMS PREVIOUSLY, PRIOR TO USE THE DEVICE AND THAT THIS WAS NOT DEVICE RELATED. BASED ON THIS, THE COMPLAINT FILE WAS UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED A/E AFTER USING THE DEVICE FOR THE 6TH STIMULATION, APPROXIMATELY 5 MINUTES AFTER TREATMENT. SHE EXPERIENCED NECK TWITCHING, LYMPH NODE AND NECK WERE SWOLLEN AND LEFT ARM WAS NUMB AND UNABLE TO MOVE, WENT TO THE EMERGENCY ROOM.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED A/E AFTER USING THE DEVICE FOR THE 6TH STIMULATION, APPROXIMATELY 5 MINUTES AFTER TREATMENT. SHE EXPERIENCED NECK TWITCHING, LYMPH NODE AND NECK WERE SWOLLEN AND LEFT ARM WAS NUMB AND UNABLE TO MOVE, WENT TO THE EMERGENCY ROOM

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS TRIED MULTIPLE TIMES TO CONTACT PATIENT TO GATHER MORE INFORMATION, NO RESPONSE FROM PATIENT. MANUFACTURER HAS CONTACTED PATIENT'S DR'S OFFICE FOR MORE INFORMATION, THEY WILL NOT PROVIDE DUE TO HIPAA.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A/E AFTER USING THE DEVICE FOR THE 6TH STIMULATION, APPROXIMATELY 5 MINUTES AFTER TREATMENT. SHE EXPERIENCED NECK TWITCHING, LYMPH NODE AND NECK WERE SWOLLEN AND LEFT ARM WAS NUMB AND UNABLE TO MOVE, WENT TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843737 GAMMACORE-S UNIT NON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE PKR ELECTROCORE, INC. 10009-40601 7384 00815203020010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other