FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2892897
·
Received December 28, 2012
Report
- Report Number
- 1627487-2012-02916
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- November 21, 2012
- Report Date
- December 5, 2012
- 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
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02917. THE PT HAD TWO PERCUTANEOUS LEADS PLACED IN THE OCCIPITAL REGION AS PART OF HER PNS SYSTEM (OFF-LABEL). IT WAS REPORTED, THE PT DID NOT LIKE THE SENSATION OF WHERE THE LEADS WERE IMPLANTED. THE PHYSICIAN REMOVED THE PT'S ENTIRE SYSTEM DUE TO THE ISSUE ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3189 | 3743126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL: 3788| SCS ANCHOR: MODEL: 1192 (2) |