FDA Adverse Event
Malfunction
Summary report: N
EONC CONVENTIONAL IPG
MDR report key: 2102839
·
Received April 12, 2011
Report
- Report Number
- 1627487-2011-01514
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 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 HIS SCS SYSTEM, INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S IPG IS DEPLETED AND IS IN "STIMULATION OFF" MODE. THE PT PLANS TO DISCUSS POSSIBLY REPLACING THE IPG WITH THE PHYSICIAN. THE NEXT COURSE OF ACTION IS CURRENTLY UNDETERMINED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EONC CONVENTIONAL IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3103958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | IMPLANT:| SCS LEAD: MODEL 3219 |