MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for GAMMACORE-S UNIT 10009-40601 manufactured by Electrocore, Inc..
[124952237]
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.
Patient Sequence No: 1, Text Type: N, H10
[124952238]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009060963-2018-00001 |
| MDR Report Key | 8002406 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-10-18 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID TALISH |
| Manufacturer Street | 150 ALLEN ROAD SUITE 201 |
| Manufacturer City | BASKING RIDGE NJ 07920 |
| Manufacturer Country | US |
| Manufacturer Postal | 07920 |
| Manufacturer Phone | 9733556713 |
| Manufacturer G1 | ELECTROCORE, INC. |
| Manufacturer Street | 150 ALLEN ROAD SUITE 201 |
| Manufacturer City | BASKING RIDGE NJ 07920 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07920 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GAMMACORE-S UNIT |
| Generic Name | NON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE |
| Product Code | PKR |
| Date Received | 2018-10-24 |
| Model Number | 10009-40601 |
| Catalog Number | 10009-40601 |
| Lot Number | 7384 |
| Device Expiration Date | 2019-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTROCORE, INC. |
| Manufacturer Address | 150 ALLEN ROAD SUITE 201 BASKING RIDGE NJ 07920 US 07920 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-24 |