FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2831533
·
Received November 5, 2012
Report
- Report Number
- 1627487-2012-12431
- Event Type
- Injury
- Date Received
- November 5, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 11, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- 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 #1627487-2012-12432. IT WAS REPORTED THE PATIENT LOST COVERAGE IN THE NECK BUT MAINTAINED COVERAGE IN HIS CHEST AND ARMS. THE SJM REPRESENTATIVE REPROGRAMMED THE SYSTEM BUT WAS UNSUCCESSFUL IN GETTING STIMULATION TO THE NECK. FOLLOW-UP DETERMINED THE PHYSICIAN ORDERED X-RAYS AND PLANS TO REVIEW THEM AT PATIENT'S FOLLOW-UP APPOINTMENT. IT WAS REPORTED THE PHYSICIAN PLANNED A TRIAL PROCEDURE TO OBTAIN COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3517851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention | SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXT: MODEL 3386 (2)| IMPLANT DATE:| IMPLANT DATE: |