MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-06 for PULSE GEN MODEL 106 manufactured by Cyberonics - Houston.
[174258103]
It was reported that the patient was experiencing swelling at the neck incision site. It was stated that the surgeon believed it to be a hematoma and that the patient was to see the surgeon. Follow up with the physician's office revealed that the hematoma was the patient's assessment and not the medical professional's. The surgeon's nurse stated that the swelling was related to blood clots/the patient's blood thinning medication being taken for a week prior to the patient being instructed to continue with the medication. The patient was hospitalized for a few days and it was stated that this was to preclude a serious injury. The event was attributed to the patient's blood clots and the patient's blood thinning medication being taken prematurely. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00045 |
| MDR Report Key | 9554215 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2020-01-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RACHEL KOHN |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | CYBERONICS - HOUSTON |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSE GEN MODEL 106 |
| Generic Name | GENERATOR |
| Product Code | MUZ |
| Date Received | 2020-01-06 |
| Model Number | 106 |
| Lot Number | 204783 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERONICS - HOUSTON |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-06 |