FDA Adverse Event
Injury
Summary report: N
OCTRODE PERCUTANEOUS LEAD
MDR report key: 1852476
·
Received September 30, 2010
Report
- Report Number
- 1627487-2010-02734
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 3, 2010
- Manufacturer
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 3. PLEASE SEE MFR REPORT #1627487-2010-02652 FOR DEVICE 1. PLEASE SEE MFR REPORT #1627487-2010-02733 FOR DEVICE 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE PERCUTANEOUS LEAD | SPINAL CORD STIMULATION LEAD | LGW | ADVANCED NEUROMODULATION SYSTEMS, INC. | 3186 | 2847790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |