FDA Adverse Event
Malfunction
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2093009
·
Received April 14, 2011
Report
- Report Number
- 1627487-2011-00503
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 16, 2011
- Manufacturer
- ST JUDE MEDICAL- NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
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
THE PATIENT WAS IMPLANTED WITH AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT IS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH HIS IPG USING EITHER THE PROGRAMMER OR THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. FOLLOW-UP ON THIS MATTER FOUND THAT THE ALLEGED PROBLEM PERSISTS WITH USE OF THE REPLACEMENT CHARGING SYSTEM. AN APPOINTMENT WILL BE SCHEDULED FOR FURTHER INTERROGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IPG, 16-CHANNEL RECHARGEABLE | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST JUDE MEDICAL- NEUROMODULATION DIVISION | 3788 | 2758858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |