FDA Adverse Event
Malfunction
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2113842
·
Received May 17, 2011
Report
- Report Number
- 1627487-2011-00684
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- March 15, 2011
- Report Date
- April 18, 2011
- 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
THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE RECHARGE TIME FOR HIS IPG HAS INCREASED. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE LATEST UNIT IS RECHARGING THE PATIENT'S IPG AT WHAT APPEARS TO BE A MORE EFFICIENT RATE.
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 | 3788 | 2799146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANTED:| SCS LEAD, MODEL: 3219 |