FDA Adverse Event
Malfunction
Summary report: N
EON IMPLANTABLE PULSE GENERATOR
MDR report key: 1934366
·
Received November 23, 2010
Report
- Report Number
- 1627487-2010-03614
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- 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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PATIENT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2006. IT WAS REPORTED THE IPG IS NO LONGER PROVIDING STIMULATION. ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE PATIENT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 47800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |