FDA Adverse Event
Injury
Summary report: N
LAMITRODE 44C SURGICAL LEAD
MDR report key: 2003828
·
Received February 24, 2011
Report
- Report Number
- 1627487-2011-02251
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- January 27, 2011
- Report Date
- January 31, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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
THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. WITHIN THE FIRST 24 HOURS POST-OPERATIVE, THE PATIENT REPORTED HE COULD NOT FEEL HIS LEGS. THE SYSTEM WAS IMMEDIATELY EXPLANTED AND NOT REPLACED. DURING THE EXPLANT, IT WAS NOTED THE PATIENT HAD DEVELOPED AN EPIDURAL HEMATOMA. THE EXPLANTED PRODUCT WAS RETAINED BY THE FACILITY. FOLLOW UP ON THE PATIENT FOUR DAYS POST-OPERATIVE FOUND THE LOSS OF FEELING IN HIS LEGS HAD NOT YET RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE 44C SURGICAL LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3245 | 2816113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R |