FDA Adverse Event
Injury
Summary report: N
PENTA LEAD KIT, 60CM LENGTH
MDR report key: 1936207
·
Received December 14, 2010
Report
- Report Number
- 1627487-2010-03922
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- SJM NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PT RECEIVED HER SCS SYS ON (B)(6) 2010. IT WAS REPORTED THAT THE PT IS EXPERIENCING A TINGLING SENSATION IN HER RIGHT RIBCAGE BOTH WHEN STIMULATION IS ON AND OFF. THE PHYSICIAN FEELS THAT THE LEAD MAY HAVE MIGRATED AND WOULD LIKE TO SURGICALLY REPOSITION IT. THE PT HAS BEEN SCHEDULED FOR A REVISION. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA LEAD KIT, 60CM LENGTH | SPINAL CORD STIMULATION LEAD | LGW | SJM NEUROMODULATION DIVISION | 3228 | 3127681 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |