MAUDE Adverse Event Report: ELECTROCORE, INC. GAMMACORE-S UNIT; NON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE

Model Number	10009-40601
Health Effect - Clinical Codes	Swollen Lymph Nodes (2093); Twitching (2172); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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
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.
Event or Problem Description
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
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.
Event or Problem Description
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.

• Brand Name: GAMMACORE-S UNIT
• Common Device Name: NON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE
• Manufacturer (Section D): ELECTROCORE, INC.; 150 allen road; suite 201; basking ridge NJ 07920
• MDR Report Key: 8002406
• Report Number: 3009060963-2018-00001
• Device Sequence Number: 289118
• Product Code: PKR
• UDI-Device Identifier: 00815203020010
• UDI-Public: 00815203020010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 10009-40601
• Device Catalogue Number: 10009-40601
• Device Lot Number: 7384
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 10/18/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 10/25/2018; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other