FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 3231821
·
Received July 15, 2013
Report
- Report Number
- 1627487-2013-11031
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 21, 2013
- 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 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
ON (B)(6) 2013, THE PATIENT UNDERWENT A PERMANENT IMPLANT PROCEDURE. DURING THE PROCEDURE, HIGH IMPEDANCE WAS FOUND. NEXT, THE LEADS WERE DISCONNECTED FROM THE IPG AND TESTED. NO ANOMALIES WERE FOUND. AS A RESULT, ANOTHER IPG WAS USED TO COMPLETE THE PROCEDURE THE PROCEDURE WAS EXTENDED FOR 15 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325360 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 4008349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |