FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2173792
·
Received July 24, 2011
Report
- Report Number
- 2124215-2011-10694
- Event Type
- Injury
- Date Received
- July 24, 2011
- Date of Event
- March 4, 2011
- Report Date
- June 20, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RIGHT VENTRICULAR LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS REMOVED AND REPLACED DUE TO DISLODGEMENT. NO ADDITIONAL 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 | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 0185| 4592| 4096| P107 |