FDA Adverse Event
Malfunction
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2062209
·
Received March 17, 2011
Report
- Report Number
- 1627487-2011-00372
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 17, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG. 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 POWER ON HIS CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AS ALL ATTEMPTS TO CONFIRM RESOLUTION HAVE BEEN UNSUCCESSFUL.
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 | 2784597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |