FDA Adverse Event
Injury
Summary report: N
60-CM LENGTH PENTA LEAD
MDR report key: 2220265
·
Received August 16, 2011
Report
- Report Number
- 1627487-2011-07063
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- 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
THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2010 FOR RIGHT LEG AND LOWER BACK PAIN. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT FELT ABDOMINAL PAIN AND LEG STIMULATION. X-RAYS REVEALED THAT THE PATIENT'S LEAD MIGRATED. PATIENT IS SCHEDULED TO BE REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 60-CM LENGTH PENTA LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3136517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |