FDA Adverse Event
Malfunction
Summary report: N
ITREL
MDR report key: 1941983
·
Received November 1, 2010
Report
- Report Number
- 3007566237-2010-08670
- Event Type
- Malfunction
- Date Received
- November 1, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 6, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE EXTENSION HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD COULD NOT BE FULLY INSERTED IN TO THE EXTENSION. THE EXTENSION WAS REPLACED. THERAPY WAS ACHIEVED AND THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL | LGW | MEDTRONIC NEUROMODULATION | IPG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB082050V |