FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2162065
·
Received July 12, 2011
Report
- Report Number
- 3007566237-2011-05355
- Event Type
- Injury
- Date Received
- July 12, 2011
- Report Date
- June 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED AN ELECTROCUTION INJURY, WHICH DISABLED THE IMPLANTED NEUROSTIMULATOR. THE DEVICE WAS REPLACED. THE PT'S STATUS WAS UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC NEUROMODULATION | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |