FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2792141
·
Received October 11, 2012
Report
- Report Number
- 1627487-2012-02499
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- February 3, 2012
- Report Date
- February 3, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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 REPORTS: 1627487-2012-02498 AND 02500. IT WAS REPORTED, THE PT HAD INEFFECTIVE STIMULATION AND HER STIMULATION FELT POSITIONAL. THE PHYSICIAN EXPLANTED HER SCS SYSTEM; HOWEVER, THE EXPLANT DATE IS CURRENTLY UNK. IT WAS REPORTED THE PHYSICIAN REPLACED THE PT'S SYSTEM WITH A PADDLE LEAD AND IPG AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3175272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2) |