FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3962493
·
Received July 14, 2014
Report
- Report Number
- 1627487-2014-00429
- Event Type
- Injury
- Date Received
- July 14, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-05242011-002-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FIELD CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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
DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2014-00430. IT WAS REPORTED THE PATIENT (B)(6) IS RECEIVING STIMULATION AT THE IPG POCKET SITE. IN ADDITION, THE OUTPUT EFFICACY OF THE PATIENT'S THERAPY SYSTEM HAS REPORTEDLY DETERIORATED. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING HAVE BEEN UNSUCCESSFUL. A DECISION REGARDING THE NEXT COURSE OF ACTION HAS NOT BEEN REACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409531 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 2799145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |