FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3082297
·
Received April 16, 2013
Report
- Report Number
- 1627487-2013-05549
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- March 3, 2011
- Report Date
- March 25, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- 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 HAS BEEN EXPERIENCING INADEQUATE STIMULATION SINCE BEING IMPLANTED. IT WAS ALSO REPORTED THE PATIENT HAS A HISTORY OF FALLING. THE PATIENT PLANS TO DISCUSS THE NEXT COURSE OF ACTION WITH HER DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163222 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3280555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANT:| SCS IPG: MODEL 3788 |