FDA Adverse Event
Injury
Summary report: N
LAMITRODE S8
MDR report key: 2852241
·
Received November 27, 2012
Report
- Report Number
- 1627487-2012-14093
- Event Type
- Injury
- Date Received
- November 27, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 7, 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: 1627487-2012-14094. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION IN HER LEG AND HIP. IT WAS ALSO REPORTED THE PT WAS EXPERIENCING EXTREME DISCOMFORT AT HER IPG SITE. THE PT UNDERWENT REVISION SURGERY WHERE HER LAMITRODE S8 LEAD WAS REPLACED WITH A PENTA LEAD AND HER IPG POCKET SITE WAS RELOCATED TO THE LEFT BUTTOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE S8 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3286 | 3463494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186| IMPLANT DATE:| IMPLANT DATE: |