FDA Adverse Event
Injury
Summary report: N
IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR
MDR report key: 17516382
·
Received August 11, 2023
Report
- Report Number
- MW5123331
- Event Type
- Injury
- Date Received
- August 11, 2023
- Report Date
- April 21, 2015
- Manufacturer
- AVERY
- Product Code
- GZE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED PATIENT HAVING EXPERIENCED ABDOMINAL DISCOMFORT AND PAIN. PATIENT DESCRIBED THE DISCOMFORT AS A FEELING LIKE THEIR STIMULATION IS ON. PATIENT HAD BEEN IMPLANTED IN 2008 AND THE DEVICE HAS NOT BEEN IN USE FOR SOME TIME. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2233731 | IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR | IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR | GZE | AVERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |