FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2903025
·
Received January 3, 2013
Report
- Report Number
- 1627487-2013-01008
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 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
- OTHER
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
REFERENCE MFR REPORT: 1627487-2013-1009. IT WAS REPORTED, THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING WAS UNABLE TO CAPTURE THE PATIENT'S SAME PAIN AREAS. THE PATIENT ALSO REPORTED EXPERIENCING ABDOMINAL STIMULATION AND OCCASIONALLY STIMULATION UP HIS BACK AND ACROSS HIS SHOULDERS. THE PATIENT WAS GIVEN A NEW PROGRAM TO TRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3706 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3511107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | SCS IPG: MODEL 3688| SCS ANCHOR| IMPLANT DATE:| IMPLANT DATE: |