FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2940684
·
Received January 30, 2013
Report
- Report Number
- 1627487-2013-02155
- Event Type
- Injury
- Date Received
- January 30, 2013
- Date of Event
- November 27, 2012
- Report Date
- January 10, 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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02156. IT WAS REPORTED THE PT HAD INEFFECTIVE STIMULATION AND SHE ALLEGED HER COVERAGE HAD NOT BEEN ADEQUATE SINCE HER REVISION PROCEDURE (REFERENCE MFR REPORT: 1627487-2012-11776). NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40289 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3571581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE: |