FDA Adverse Event
Injury
Summary report: N
LAMITRODE 44
MDR report key: 2992484
·
Received March 4, 2013
Report
- Report Number
- 1627487-2013-03311
- Event Type
- Injury
- Date Received
- March 4, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- 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 SCS LEAD HAS INVALID IMPEDANCE VALUES. FOLLOW-UP IDENTIFIED X-RAYS SHOWED THE SCS LEAD IS FRACTURED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 91583 | LAMITRODE 44 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3262 | 3732524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | IMPLANT:| SCS IPG: MODEL 3788 |