FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 3820966
·
Received May 12, 2014
Report
- Report Number
- 1627487-2014-25374
- Event Type
- Injury
- Date Received
- May 12, 2014
- Date of Event
- January 1, 2013
- Report Date
- April 21, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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. REFERENCE MFR REPORT#: 1627487-2014-25114 AND 1627487-2014-25375.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284103 | QUATTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3146 | 37344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | IMPLANT DATE:| SCS IPG: MODEL 3716| SCS EXTENSION: MODEL 3341| IMPLANT DATE: |