FDA Adverse Event
Malfunction
Summary report: N
EON PATIENT PROGRAMMER
MDR report key: 2844253
·
Received November 8, 2012
Report
- Report Number
- 1627487-2012-01995
- Event Type
- Malfunction
- Date Received
- November 8, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- ADVANCED NEUROMODULATION SYSTEMS
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- 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 HE PT'S SCS PROGRAMMER IS MALFUNCTIONING. A REPLACEMENT SCS PROGRAMMER WAS SENT TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON PATIENT PROGRAMMER | SCS PROGRAMMER | LGW | ADVANCED NEUROMODULATION SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention | IMPLANTED:| IMPLANTED:| SCS IPG, MODEL 3788| SCS LEAD: MODEL 3219 |