FDA Adverse Event
Malfunction
Summary report: N
EON MINI IMPLANTABLE PULSE GENERATOR
MDR report key: 2043291
·
Received February 25, 2011
Report
- Report Number
- 1627487-2011-02252
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. THE PT REPORTED THAT WHEN HIS THERAPIES ARE ENABLED AND HE LIES DOWN, HE CAN FEEL AN UNCOMFORTABLE STIMULATION IN HIS CHEST. IN ADDITION, THE PT IS HAVING DIFFICULTY ESTABLISHING TELEMETRY WITH THE IPG. FOLLOW UP ON THE PT FOUND HE IS WORKING CLOSELY WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 13608860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |