FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2881435
·
Received December 17, 2012
Report
- Report Number
- 1627487-2012-12794
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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
IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN IN BACK AND RIBS WHEN STIMULATION IS ON OR OFF. X-RAYS REVEALED LEADS HAVE NOT MIGRATED. THE PHYSICIAN WILL SEE THE PATIENT IN A FEW WEEKS TO REASSESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3778261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | IMPLANT DATE:| SCS IPG, MODEL 3788 |