FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1220437
·
Received November 4, 2008
Report
- Report Number
- 3004209178-2008-07161
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 8, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT'S DEVICES WERE REMOVED DUE TO INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | Required Intervention | PROGRAMMER: MODEL 7434A| IMPLANTED:| EXTENSION: MODEL 7495-51| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487 LOT # J0124844V |