FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2881430
·
Received December 17, 2012
Report
- Report Number
- 1627487-2012-14204
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- January 27, 2011
- Report Date
- January 27, 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 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
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-14205. IT WAS REPORTED THE PATIENT'S LEADS WERE REPLACED WITH NEW ONES AND EXTENSIONS WERE ALSO ADDED. THE REASON FOR THE LEAD REPLACEMENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 2781314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention | IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1194 (2) |