FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2891690
·
Received December 12, 2012
Report
- Report Number
- 1627487-2012-13204
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- November 16, 2012
- Report Date
- November 16, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 3: REFERENCE MFR REPORT: 1627487-2012-13203, REFERENCE MFR REPORT: 1627487-2012-13205. IT WAS REPORTED THE PT WAS EXPERIENCING HEADACHES WHEN HER STIMULATION WAS ON. SHE ALSO STATED SHE WAS EXPERIENCING DISCOMFORT AT HER IPG SITE. HER LEADS WERE REPOSITIONED BY HER PHYSICIAN. THE PHYSICIAN OPTED TO ALSO MOVE HER IPG TO A DIFFERENT AREA IN THE POCKET AND SECURE HER IPG. THE ISSUE WITH HER HEADACHES WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3189 | 3269067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | SCS ANCHOR: MODEL 1192 (2)| IMPLANT: |