FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3954943
·
Received July 16, 2014
Report
- Report Number
- 1627487-2014-05502
- Event Type
- Injury
- Date Received
- July 16, 2014
- Report Date
- August 5, 2016
- Manufacturer
- ST JUDE MEDICAL NEUROMODULATION
- Product Code
- GZB
- 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.
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 3 OF 3. REFER TO MFR REPORTS 1627487-2013-05268, 1627487-2013-05269.
Description of Event or Problem · 1
DEVICE 3 OF 3: REFERENCE MFR. REPORT#: 1627487-2013-05268, REFERENCE MFR. REPORT#: 1627487-2013-05269.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416032 | EON MINI | SCS IPG | GZB | ST JUDE MEDICAL NEUROMODULATION | 3788 | 3895944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |