FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 3963598
·
Received May 21, 2014
Report
- Report Number
- 1627487-2014-05362
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 22, 2012
- Report Date
- April 29, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMOUDLATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-05242011-002-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RECALL: 1627487-07262012-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER IS INCLUDED IN FIELD ADVISORIES. 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
IT WAS REPORTED THE CHARGER AND PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. AS A RESULT, THE PATIENT HAS LOST STIMULATION. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT TO PROVIDE RESOLUTION TO NO AVAIL. IN TURN, AN SJM REPRESENTATIVE WILL MEET WITH THE PATIENT FOR TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303977 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMOUDLATION | 3788 | 172703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | IMPLANT DATE:| IMPLANT DATE:| SCS LEADS: MODEL 3186| SCS ANCHORS: MODEL 1194 |