FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1874878
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17834
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SUCCESSFULLY REPLACED BUT WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS EXPLANTED DUE TO INADEQUATE CAPTURE. IT WAS SUSPECTED THAT THE LEAD HAD DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |