FDA Adverse Event
Injury
Summary report: N
LAMITRODE 44C
MDR report key: 2902975
·
Received December 26, 2012
Report
- Report Number
- 1627487-2012-12832
- Event Type
- Injury
- Date Received
- December 26, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S LEAD MIGRATED TO THE POCKET SITE. THE PHYSICIAN REPOSITIONED THE LEAD ON (B)(6) 2012. REPORTEDLY THE PATIENT HAS EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE 44C | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3245 | 3253472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | SCS ANCHOR, MODEL 1192| IMPLANT DATE:| SCS LEAD, MODEL 3163| IMPLANT DATE: |