FDA Adverse Event
Injury
Summary report: N
LAMITRODE S8
MDR report key: 4113010
·
Received September 17, 2014
Report
- Report Number
- 1627487-2014-25615
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 26, 2014
- Manufacturer
- ST JUDE MED - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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
IT WAS REPORTED THE PT (B)(6) WAS EXPERIENCING UNCOMFORTABLE STIMULATION AND WAS UNABLE TO INCREASE AMPLITUDE. LEAD DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE MEASUREMENTS. AN SJM REP MET WITH THE PT FOR REPROGRAMMING AND WAS ABLE TO PROVIDE STIMULATION. HOWEVER, THE PT MAY UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO ADDRESS THE IMPEDANCE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574466 | LAMITRODE S8 | SCS LEAD | GZB | ST JUDE MED - NEUROMODULATION | 3286 | 4430433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |