FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 3954921
·
Received July 16, 2014
Report
- Report Number
- 1627487-2014-12478
- Event Type
- Injury
- Date Received
- July 16, 2014
- Date of Event
- December 1, 2013
- Report Date
- June 20, 2014
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THAT THE PATIENT HAS NOT USED OR CHARGED HER SCS SYSTEM FOR APPROXIMATELY SEVEN MONTHS. AS A RESULT THE IPG IS DEPLETED. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416315 | EON | SCS IPG | GZB | ST JUDE MEDICAL - NEUROMODULATION | 3716 | 112711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | SCS LEAD: MODEL 3214,| IMPLANT DATE: |