FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 2861050
·
Received December 3, 2012
Report
- Report Number
- 1627487-2012-02735
- Event Type
- Injury
- Date Received
- December 3, 2012
- Date of Event
- March 27, 2012
- Report Date
- March 27, 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 INFO 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
THE PT RECEIVED TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PT EXPERIENCED INEFFECTIVE STIMULATION COVERAGE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEADS AND IMPLANT AN ADDITIONAL LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3146 | 3110796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | SCS IPG: MODEL 3688| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (3)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE: |