FDA Adverse Event
Malfunction
Summary report: N
EON MINI IMPLANTABLE PULSE GENERATOR
MDR report key: 2062198
·
Received March 17, 2011
Report
- Report Number
- 1627487-2011-00983
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- ADVANCED NEUROMODULATION SYSTEMS
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT FELL IN (B)(6) 2010, AND A FEW WEEKS AFTER THE FALL, SHE BEGAN EXPERIENCING HEATING AROUND THE IPG. THE PATIENT ALSO REPORTED THAT STIMULATION OCCASIONALLY MAKES HER FEEL NAUSEOUS. THE PATIENT'S SYSTEM WAS REPROGRAMMED. IT WAS REPORTED THAT THE PATIENT'S SITUATION WILL BE REASSESSED IN THE FUTURE. NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ADVANCED NEUROMODULATION SYSTEMS | 3788 | 3079787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |