FDA Adverse Event
Injury
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2000752
·
Received February 17, 2011
Report
- Report Number
- 1627487-2011-00193
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION PULSE GENERATOR
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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
THE PATIENT WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT SHE IS UNABLE TO LOCATE THE IPG VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. FOLLOW-UP ON THE PATIENT FOUND THAT THE ALLEGED PROBLEM PERSISTS WITH USE OF THE REPLACEMENT UNIT. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPOSITION THE PATIENT'S IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IPG, 16-CHANNEL RECHARGEABLE | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST JUDE MEDICAL - NEUROMODULATION PULSE GENERATOR | 3788 | 3213668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |