FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 3950504
·
Received July 10, 2014
Report
- Report Number
- 1627487-2014-12464
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 12, 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 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
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. THE IPG WAS EXPLANTED AND REPLACED. THE PATIENT REPORTED EFFECTIVE STIMULATION THERAPY POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403963 | EON | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 174669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | IMPLANT DATE:| SCS LEAD, MODEL: 3224 |