FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2890788
·
Received December 21, 2012
Report
- Report Number
- 1627487-2012-12831
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- 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 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 2. REFERENCE MFR REPORT: 1627487-2012-12830. IT WAS REPORTED, THE PT WAS NOT RECEIVING ADEQUATE STIMULATION COVERAGE. X-RAYS REVEALED THE LEAD HAD MIGRATED. THE PHYSICIAN RELOCATED THE LEAD ON (B)(6) 2012. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POST OPERATIVE. NOTE: THE PT HAS TWO LEADS WITH DIFFERENT LOT NUMBERS IMPLANTED. BOTH LEADS ARE BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3229490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3788 |