FDA Adverse Event
Injury
Summary report: N
LAMITRODE 88
MDR report key: 3110635
·
Received May 10, 2013
Report
- Report Number
- 1627487-2013-08081
- Event Type
- Injury
- Date Received
- May 10, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 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 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 PT'S LEAD HAD MIGRATED LATERALLY SO, IT WAS REPLACED WITH A NEW ONE. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208771 | LAMITRODE 88 | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3288 | 2850534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3788 |