FDA Adverse Event
Malfunction
Summary report: N
QUATTRODE
MDR report key: 3250074
·
Received July 23, 2013
Report
- Report Number
- 1627487-2013-04938
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Date of Event
- February 28, 2013
- Report Date
- July 2, 2013
- Manufacturer
- ST. JUDE MEDICAL, NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- K072462
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-04937.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344388 | QUATTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL, NEUROMODULATION | 3166 | 3218964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | SCS IPG: MODEL 3788| IMPLANT DATE: |