MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-11 for LEAD MODEL 7304 manufactured by Livanova Usa, Inc..
[178586668]
It was reported for a clinical trial patient that the patient experienced a neck burn with causality reported to be "probably related' to device implantation surgery, with rationale "patient got a burn on his neck, either as an allergic reaction or from the electrode of the electrocautery". It is not related to device stimulation or system, there was no action taken with the treatment. Non-drug treatment was required. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00227 |
| MDR Report Key | 9694229 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-11 |
| 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 | LEAD MODEL 7304 |
| Generic Name | LEAD |
| Product Code | MUZ |
| Date Received | 2020-02-11 |
| Model Number | 7304 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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; 2. Required No Informationntervention | 2020-02-11 |