FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 3831947
·
Received March 6, 2014
Report
- Report Number
- 1627487-2014-05177
- Event Type
- Malfunction
- Date Received
- March 6, 2014
- Report Date
- February 13, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-12192011-003-R,
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG NUMBER IS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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 PT HAS NOT RECHARGED THE IPG AS RECOMMENDED. IN TURN, THE PT HAS LOST STIMULATION AND THE CHARGER/PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. AN SJM REP MET WITH THE PT ON (B)(6) 2014 AND THE IPG WAS CONFIRMED TO BE INOPERABLE. AS A RESULT, THE PT WILL UNDERGO SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135150 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3148358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |