FDA Adverse Event
Injury
Summary report: N
LAMITRODE 44 60-CM LENGTH PADDLE LEAD
MDR report key: 2181351
·
Received July 21, 2011
Report
- Report Number
- 1627487-2011-03324
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- August 24, 2010
- Report Date
- June 22, 2011
- 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 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
THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT COULD ONLY GET RIB AND ABDOMINAL STIMULATION. IT WAS THEN DECIDED TO REPLACE THE LEAD ON (B)(6) 2010. THE PT STATED HE IS GETTING THE SAME RIB AND ABDOMINAL STIMULATION WITH THE REPLACED LEAD (REFER TO 1627487-2011-03325).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE 44 60-CM LENGTH PADDLE LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3244 | 2828639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL: 1194| SCS IPG, MODEL: 3716 |