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 2020-01-24 for PULES GEN MODEL 105 manufactured by Livanova Usa, Inc..
[176262551]
Patient reported being in the emergency room due to 2 episodes during which the patient felt like she was having a seizure or stroke. The patient reported that she put the magnet over the generator and this stopped the event. Further information was received that the patient? S device was disabled. A ct scan was performed and no stroke was observed on the scan. The emergency room doctor reported that he felt the cause of the event was the device. It was further noted that the patient does not have epilepsy or seizures. No other relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00109 |
| MDR Report Key | 9627882 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-24 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2014-12-11 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| 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 | LIVANOVA USA, INC. |
| 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 | PULES GEN MODEL 105 |
| Generic Name | GENERATOR |
| Product Code | MUZ |
| Date Received | 2020-01-24 |
| Model Number | 105 |
| Lot Number | 203191 |
| Device Expiration Date | 2016-11-12 |
| 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 | LIVANOVA USA, INC. |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-24 |