FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 2881088
·
Received December 14, 2012
Report
- Report Number
- 1627487-2012-13223
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 19, 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 INFO 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 2 OF 3. REF MFR REPORT: 1627487-2012-13222, AND -13224. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE THERAPY FROM HER SCS SYSTEM. SURGICAL INTERVENTION IS SCHEDULED FOR A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3156 | 97141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS EXTENSION: MODEL 3342| IMPLANT DATE: |