FDA Adverse Event
Injury
Summary report: N
OCTRODE 3/4 PERCUTANEOUS LEADS
MDR report key: 1870937
·
Received October 8, 2010
Report
- Report Number
- 1627487-2010-02776
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. 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 (FRACTURED LEAD). PLEASE SEE MFR REPORT #1627487-2010-02757 FOR DEVICE 1 AND MFR REPORT #1627487-2010-02777 FOR DEVICE 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE 3/4 PERCUTANEOUS LEADS | SPINAL CORD STIMULATION LEAD | LGW | ADVANCED NEUROMODULATION SYSTEMS, INC. | 3186 | 84417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |