FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2875167
·
Received December 13, 2012
Report
- Report Number
- 1627487-2012-14184
- Event Type
- Injury
- Date Received
- December 13, 2012
- Date of Event
- November 16, 2012
- Report Date
- November 21, 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 INFORMATION 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: 1627487-2012-14185. IT WAS REPORTED, THE PT IS NO LONGER RECEIVING STIMULATION. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND SHOWED THE LEADS HAVE PULLED OUT OF THE EPIDURAL SPACE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3769673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: |