FDA Adverse Event
Injury
Summary report: N
OCTRODE PERCUTANEOUS LEAD
MDR report key: 2023333
·
Received March 16, 2011
Report
- Report Number
- 1627487-2011-01253
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- December 21, 2010
- Report Date
- February 15, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01061.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE PERCUTANEOUS LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION DIVISION | 3186 | 3108614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |