FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2934518
·
Received January 28, 2013
Report
- Report Number
- 1627487-2013-04124
- Event Type
- Injury
- Date Received
- January 28, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 1, 2013
- 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 3. REFERENCE MFR REPORT: 1627487-2013-04125, 1627487-2013-04126. IT WAS REPORTED THE PATIENT HAD INADEQUATE STIMULATION COVERAGE. THE PHYSICIAN REPLACED THE CERVICAL LEAD, THE EXTENSION, AND THE IPG. IT WAS REPORTED THE IPG WAS REPLACED AND REPOSITIONED TO THE LEFT FLANK; IT WAS UNDETERMINED WHY THE IPG WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37774 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3183 | 115313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3186| IMPLANT DATE: |