FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1242953
·
Received November 21, 2008
Report
- Report Number
- 3004209178-2008-07650
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT LOST 35-40 POUNDS DUE TO MEDICAL PROBLEMS. THE TISSUE OVER THE NEUROSTIMULATOR THINNED WITH SOME SKIN EROSION. THERE WERE NO SIGNS OF INFECTION. THE POCKET WAS REVISED. THE PATIENT WAS REPORTED TO BE DOING WELL. THE INCISION HAD HEALED AND THERE WERE NO SIGNS OF INFECTION IN THE POCKET POSTSURGICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | LEAD MODEL 3587A| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434A| PROGRAMMER: MODEL 7434 |