FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2926028
·
Received January 17, 2013
Report
- Report Number
- 1627487-2013-05100
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- November 29, 2012
- Report Date
- December 10, 2012
- 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 INFO 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
ON (B)(6) 2012, THE PT'S IPG AND LEADS WERE EXPLANTED AD REPLACED (REF MFR REPORT#: 1627487-2013-12075 AND 1627487-2013-12076). POST-OP, THE PT EXPERIENCED NUMBNESS IN HER LEGS. AS A RESULT, THE PT WAS HOSPITALIZED AND IS UNDERGOING PHYSICAL THERAPY USING A WALKER AND WHEELCHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25590 | PENTA | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3228 | 3838189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R | SCS IPG: MODEL 3788| SCS ANCHORS: MODEL 1192 (X2)| IMPLANT:| IMPLANT: |