FDA Adverse Event
Injury
Summary report: N
OCTRODE PERCUTANEOUS LEAD
MDR report key: 2000661
·
Received February 16, 2011
Report
- Report Number
- 1627487-2011-02209
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- October 1, 2010
- Report Date
- January 24, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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
THE PT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THE LEADS WILL BE EXPLANTED AND REPLACED DUE TO MIGRATION. IT IS UNK WHETHER THE LEADS WILL BE RETURNED TO THE MFR FOR ANALYSIS ONCE EXPLANTED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.
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 | 3071334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |