FDA Adverse Event
Malfunction
Summary report: N
EON MINI IMPLANTABLE PULSE GENERATOR
MDR report key: 1930157
·
Received November 18, 2010
Report
- Report Number
- 1627487-2010-03571
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 22, 2010
- Manufacturer
- ST. JUDE MEDICAL -NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. THE PT REPORTED THAT SINCE HER LAST REPROGRAMMING SESSION, HER DEVICE IS REQUIRING MORE FREQUENT RECHARGES. THE PT IS CONTINUING TO WORK WITH HER PHYSICIAN REGARDING FUTURE REPROGRAMMING CONFIGURATIONS WHICH MAY REQUIRE LESS POWER. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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 | 175972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |