FDA Adverse Event
Injury
Summary report: N
PENTA SURGICAL LEAD
MDR report key: 1990684
·
Received February 8, 2011
Report
- Report Number
- 1627487-2011-01108
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION DIV
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION 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 SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2010 FOR LOW BACK AND LEG PAIN. IT WAS REPORTED THAT THE PT WAS HAVING DIFFICULTY CONTROLLING HER BLADDER. SHE STATED THAT SHE HAS ALWAYS HAD BLADDER CONTROL PROBLEMS, BUT THE SYMPTOMS HAD WORSENED SINCE HER SCS SYSTEM WAS IMPLANTED. THE SYSTEM HAS NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA SURGICAL LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION DIV | 3228 | 3190281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |