FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2101939
·
Received May 18, 2011
Report
- Report Number
- 3004209178-2011-03643
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- February 1, 2011
- Report Date
- April 20, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THERE WAS AN OVERSTIMULATION SENSATION WHILE LYING IN BED. A HIGH IMPEDANCE WAS REPORTED ON ONE ELECTRODE. THE PT WAS AT HOME AND STATUS WAS REPORTED AS FAIR. HEALTH CARE PROVIDER DID NOT KNOW IF THIS WAS DEVICE RELATED AND ADVISED PT TO TURN AMPLITUDE DOWN AT NIGHT. THE PT OUTCOME WAS REPORTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| LEAD: MODEL 3487A, LOT# V077829| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU153270V| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL034332P |