FDA Adverse Event
Injury
Summary report: N
SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM
MDR report key: 6142010
·
Received December 2, 2016
Report
- Report Number
- 3005868392-2016-00003
- Event Type
- Injury
- Date Received
- December 2, 2016
- Date of Event
- November 1, 2016
- Report Date
- December 1, 2016
- Manufacturer
- SYNAPSE BIOMEDICAL INC.
- Product Code
- OIR
- UDI-DI
- 00852184003007
- PMA / PMN Number
- H070003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS EXPERIENCING RECURRING INFECTIONS AT THE PERCUTANEOUS EXIT SITE OF THE LEAD WIRES OF THE DIAPHRAGM PACING SYSTEM. THE CAREGIVER FOR THE PATIENT WAS INSTRUCTED ON PROPER EXIT SITE CARE BUT THE INFECTION DID NOT CLEAR WITH THIS INTERVENTION. A COURSE OF ANTIBIOTIC TREATMENT CLEARED THE INFECTION BUT INFECTION RECURRED WHEN THE ANTIBIOTIC TREATMENT ENDED. THE ATTENDING PHYSICIAN DECIDED TO EXPLANT THE ELECTRODES AND DEBRIDE THE AREA, WHICH TOOK PLACE ON (B)(6) 2016. RECOVERY WAS NORMAL FOLLOWING THE EXPLANT AND THE PATIENT MAY BE REIMPLANTED AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792754 | SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM | DIAPHRAGM PACER | OIR | SYNAPSE BIOMEDICAL INC. | 20-0035 | 20-0035-102815-3-3 | 00852184003007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |