FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1941165
·
Received December 22, 2010
Report
- Report Number
- 3004209178-2010-10672
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 9, 2010
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED GENERAL PAIN/DISCOMFORT, SHOCKING PAINS IN HEAD, NON-MIGRAINE HEADACHES, BURNING AND THROBBING SENSATIONS WITH THE STIMULATION ON FOLLOWING A FALL DOWN THE STAIRS. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | 43 YR | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL036143P| LEAD: MODEL 3587, LOT# N133913| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU105593V| IMPLANTED: |