FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 2102687
·
Received May 19, 2011
Report
- Report Number
- 3007566237-2011-03682
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 22, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRIAL PT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN TRYING TO CHANGE PROGRAMS. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. NO FURTHER SYMPTOMS OR INJURY WERE REPORTED. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PROGRAMMER: MODEL 37743, LOT# UNK |