FDA Adverse Event
Injury
Summary report: N
NEURX DIAPHRAGM PACING SYSTEM
MDR report key: 5266871
·
Received December 1, 2015
Report
- Report Number
- 3005868392-2015-00004
- Event Type
- Injury
- Date Received
- December 1, 2015
- Date of Event
- October 1, 2015
- Report Date
- October 27, 2015
- Manufacturer
- SYNAPSE BIOMEDICAL INC.
- Product Code
- OIR
- UDI-DI
- 00852184003281
- PMA / PMN Number
- H100006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 1
Narratives
Description of Event or Problem · 1
PATIENT HAD WIRES PROTRUDING FROM THE SKIN. ELECTRODES VISIBLE IN OPEN WOUND NEAR SUB-XYPHOID EXIT/TUNNELING POINT. THE ELECTRODE WAS INITIALLY TUNNELED NEAR THE SKIN SURFACE, EVENTUALLY ERODED THROUGH THE SKIN, EXPOSING ELECTRODE UNDERNEATH. SURGEON RETRACTED THE ELECTRODES FROM LATERAL CHEST AREA TO SUB XIPHOID REGION WHERE THEY WERE TRIMMED AND REBLOCKED. PATIENT CONTINUES TO USE DPS SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789411 | NEURX DIAPHRAGM PACING SYSTEM | DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR | OIR | SYNAPSE BIOMEDICAL INC. | 20-0045 | 20-0045-120511-4-3 | 00852184003281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |