FDA Adverse Event
Malfunction
Summary report: N
EON MINI IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 2113838
·
Received May 17, 2011
Report
- Report Number
- 1627487-2011-00683
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- March 29, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE RECHARGE TIME FOR HIS IPG HAS INCREASED SINCE THE RECEIPT OF HIS NEW CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, ANOTHER CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE PT THE LATEST UNIT IS RECHARGING HIS IPG AT WHAT APPEARS TO BE A MORE EFFICIENT RATE; HOWEVER, HE HAS AN APPOINTMENT WITH THE PHYSICIAN NEXT WEEK.
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 | 3190240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | IMPLANT:| SCS LEAD: MODEL: 3166| SCS LEAD EXTENSION: MODEL: 3341| SCS LEAD: MODEL: 3163| IMPLANT:| IMPLANT: |