FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2892259
·
Received December 27, 2012
Report
- Report Number
- 1627487-2012-03936
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- November 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 WAS NOT RECEIVING EFFECTIVE STIMULATION. SUBSEQUENTLY, THE PATIENT'S SCS IPG WAS SCHEDULED FOR EXPLANT. FOLLOW-UP IDENTIFIED THE EXPLANT WAS CANCELLED DUE TO THE PATIENT ARRIVING AT THE OPERATING ROOM WITH A FEVER AND VOMITING. FURTHER FOLLOW-UP IDENTIFIED THE PATIENT HAD STOPPED USING HER SCS SYSTEM SOME TIME AGO DUE TO IMPROVED PAIN AND NO LONGER NEEDING THE SCS SYSTEM. THE PATIENT HAS REQUESTED THAT HER SCS SYSTEM BE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 171281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | IMPLANT DATE:| SCS LEAD, MODEL 3224 (2) |