FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1951639
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-24050
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 26, 2010
- Report Date
- November 26, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING HIGH THRESHOLDS AND UNDERSENSING SOME VENTRICULAR FIBRILLATION AND IT WAS BELIEVED TO HAVE MICRODISLODGED. AT THE MOST RECENT UPGRADE PROCEDURE THE DECISION WAS MADE TO SURGICALLY ABANDON AND REPLACE THIS LEAD. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | MISMATCH| 4087| 0148| T167| N119| 7121| 1861 |