FDA Adverse Event
Injury
Summary report: N
OCTRODE PERCUTANEOUS LEAD
MDR report key: 2120963
·
Received June 9, 2011
Report
- Report Number
- 1627487-2011-01640
- Event Type
- Injury
- Date Received
- June 9, 2011
- Date of Event
- May 11, 2011
- Report Date
- May 11, 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 HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. IT WAS REPORTED THE LEAD WAS SURGICALLY REPOSITIONED DUE TO LEAD MIGRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE PERCUTANEOUS LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3194952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANT:| SCS ANCHOR: MODEL 1192| IMPLANT:| SCS IPG: MODEL 3788 |