FDA Adverse Event
Malfunction
Summary report: N
ITREL II
MDR report key: 1449794
·
Received May 22, 2009
Report
- Report Number
- 6000032-2009-03618
- Event Type
- Malfunction
- Date Received
- May 22, 2009
- Report Date
- April 27, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELL ON THEIR CHEST. SINCE THE FALL THE PT HAS NOT BEEN FEELING WELL AND HAS EXPERIENCED TREMORING. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER REPORT #6000032-2009-03617.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL II | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7424 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTABLE NEURO STIMULATOR: MODEL 7424| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389| EXPLANTED:| LEAD: MODEL 3389| PROGRAMMER: MODEL 7438| EXTENSION: MODEL 7495-51| EXPLANTED:| IMPLANTED:| LOT# QT2137737H| IMPLANTED: |