FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 4112975
·
Received September 17, 2014
Report
- Report Number
- 1627487-2014-20233
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- July 22, 2014
- Report Date
- August 28, 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 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 EXPERIENCED PAIN AT THE IPG SITE WITH STIMULATION. AS A RESULT, PT IS NO LONGER USING HER SCS SYSTEM. THE PT IS TO CONSULT WITH THE PHYSICIAN REGARDING THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577082 | EON | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 119940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | SCS LEAD: MODEL 3219| IMPLANT DATE: |