FDA Adverse Event
Injury
Summary report: N
LAMITRODE 8
MDR report key: 2903187
·
Received January 2, 2013
Report
- Report Number
- 1627487-2013-00019
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- September 18, 2006
- Report Date
- December 7, 2012
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MED 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 MED HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S ((B)(6)) LEAD WAS EXPLANTED AND REPLACED. THIS INFO WAS DISCOVERED BY THE MFR AFTER REVIEWING THE PT'S FILES. THE REASON FOR THE PROCEDURE IS UNK. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1052 | LAMITRODE 8 | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3280 | 27085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |