FDA Adverse Event
Injury
Summary report: N
EONC
MDR report key: 3850659
·
Received May 29, 2014
Report
- Report Number
- 1627487-2014-02371
- Event Type
- Injury
- Date Received
- May 29, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 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 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
IT WAS REPORTED THE PT'S SCS IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317299 | EONC | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3117703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | SCS LEAD ADAPTER: MODEL 2343| IMPLANT DATE: |