FDA Adverse Event
Injury
Summary report: N
OCTRODE PERCUTANEOUS LEAD
MDR report key: 2251364
·
Received September 13, 2011
Report
- Report Number
- 1627487-2011-05132
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- August 14, 2011
- Report Date
- August 15, 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
MANUFACTURER'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. SJM HAS LIMITED INFO 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
DEVICE 2 OF 3. REFERENCE MFR REPORT#: 1627487-2011-05131, REFERENCE MFR. REPORT#: 1627487-2011-05133.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE PERCUTANEOUS LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3179691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |