FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2090892
·
Received April 26, 2011
Report
- Report Number
- 3007566237-2011-03091
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 7, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD WAS OPENED FOR IMPLANT. THE BENT/GREEN STYLET COULD NOT BE INSERTED INTO THE LEAD BECAUSE IT SEEMED TO STOP ADVANCING INTO THE LEAD AT A "CERTAIN POINT." THE LEAD WAS NOT USED FOR IMPLANT, AND ANOTHER LEAD WAS USED INSTEAD. THERE WAS NO EFFECT ON THE PT AND THE IMPLANT WENT WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| LEAD: MODEL 3877, LOT# 0204737485| EXPLANTED: |