FDA Adverse Event
Malfunction
Summary report: N
IPG NEURO
MDR report key: 1191501
·
Received July 31, 2008
Report
- Report Number
- 2182207-2008-04550
- Event Type
- Malfunction
- Date Received
- July 31, 2008
- Date of Event
- February 2, 2008
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LYJ
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A PT WITH A VAGAL NERVE STIMULATOR EXPERIENCED A LEAD BREAKAGE. NO OTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IPG NEURO | LGW | LYJ | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | LEAD MODEL: UNK LOT# UNK IMPLANTED:| EXPLANTED: |