FDA Adverse Event
Injury
Summary report: N
THINLINE EZ
MDR report key: 747148
·
Received August 9, 2006
Report
- Report Number
- 2124215-2006-99470
- Event Type
- Injury
- Date Received
- August 9, 2006
- Date of Event
- June 16, 2006
- Manufacturer
- ITM
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED. EVENT CONCLUSION A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THEREFORE, GUIDANT CANNOT CONFIRM THE CLINICAL OBSERVATION. LEAD DAMAGE IS NORMALLY A RESULT OF LEAD ON LEAD CONTACT OR LEAD ROUTING THROUGH THE BODY. IF ADDITIONAL INFORMATION IS OBTAINED, THIS EVENT WILL BE REOPENED.
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD FRACTURED, CAUSING RESISTANCE UP TO 2500 OHMS. THIS LEAD WAS ABANDONED SURGICALLY, AND A NEW RV LEAD WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THINLINE EZ | IMPLANTABLE LEAD | DTB | ITM | 438-10 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 1280| 430-10| 4456 |