FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 4092166
·
Received September 3, 2014
Report
- Report Number
- 1627487-2014-24146
- Event Type
- Injury
- Date Received
- September 3, 2014
- Date of Event
- August 9, 2014
- Report Date
- August 11, 2014
- Manufacturer
- ST. JUDE MED - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2014-24145. IT WAS REPORTED THE PATIENT EXPERIENCED NECK PAIN AND AN ACCUMULATION OF FLUID BUILT UP IN HIS NECK. THE PATIENT WENT TO THE EMERGENCY ROOM. ANTIBIOTICS WERE PRESCRIBED. FOLLOW-UP REVEALED NO SIGNS OF INFECTION, FLUID BUILD UP OR SWELLING WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535447 | PENTA | SCS LEAD | GZB | ST. JUDE MED - NEUROMODULATION | 3228 | 4444348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other | IMPLANT DATE:| SCS EXTENSION: MODEL 3383(2)| SCS IPG: MODEL 3788| IMPLANT DATE: |