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 2020-01-13 for PULSE GEN MODEL 106 manufactured by Cyberonics - Houston.
[174894559]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174894560]
It was reported by the patient that she experienced a fluttering in her chest that stops with magnet disablement. The patient stated that this resulted in elevated blood pressure and not sleeping well. The patient later called and described the fluttering as? An electrical charge encapsulated in her chest.? The patient has been feeling nervous and agitated since the event began. The patient also stated that she felt fatigue and heaviness in her body until she magnet disabled the vns. The patient later reported that she was feeling fatigued and experienced nausea similar in the past when she had an implanted device that contained nickel. The vns lead contains a nickel alloy, but the alloy is encased in silicone and not in contact with the body unless there is an issue. The patient stated that at the last physician's office visit, the diagnostics were "alright". The patient stated that her vns settings were lowered at that time, but the side effects were still lingering. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00075 |
| MDR Report Key | 9581472 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | 106 |
| Lot Number | 204717 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2020-01-13 |