FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3231508
·
Received July 12, 2013
Report
- Report Number
- 1627487-2013-12927
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- May 15, 2013
- Report Date
- June 17, 2013
- 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
DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2013-12926. IT WAS REPORTED ONE OF THE PATIENT'S OCCIPITAL LEADS (OFF-LABEL USE), FROM DIFFERENT LOTS, HAS BECOME MORE SUPERFICIAL CAUSING REDNESS AND IRRITATION. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2013 AND THE PATIENT REPOSITIONED THE LEAD ON (B)(6) 2013. THE PHYSICIAN DID NOT SEE ANY SIGNS OF INFECTION AND NO DEVICES WERE EXPLANTED AND NO NEW DEVICES WERE ADDED. FOLLOW-UP REVEALED THE PATIENT IS HEALING AND HAS EFFECTIVE STIMULATION COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323696 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3189 | 3498068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization | IMPLANT DATE:| SCS IPG: MODEL 3788 |