FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2980312
·
Received February 22, 2013
Report
- Report Number
- 1627487-2013-15259
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- January 29, 2013
- Report Date
- February 1, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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
IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED ONE DAY AFTER BEING IMPLANTED DUE TO AN EPIDURAL HEMATOMA. FOLLOW-UP INFORMATION INDICATED THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL AND HE HAD DISPROPORTIONATE BACK PAIN AND SUBSEQUENTLY DEVELOPED LOWER EXTREMITY WEAKNESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77242 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3874035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R | SCS IPG: MODEL 3788| IMPLANT DATE: |