FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 1823417
·
Received August 25, 2010
Report
- Report Number
- 1627487-2010-02487
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 28, 2010
- Report Date
- July 12, 2010
- Manufacturer
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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 4. SEE MFR# 1627487-2010-01969, MFR# 1627487-2010-02488, MFR# 1627487-2010-02489.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | PERCUTANEOUS LEAD | LGW | ADVANCED NEUROMODULATION SYSTEMS, INC. | 3186 | 3088705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |