FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1952302
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-24486
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. ALL OTHER MEASUREMENTS WERE STABLE AND ACCEPTABLE. THERE WAS NO NOISE ON THE ELECTROGRAM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT NO CHANGES HAVE BEEN MADE. AT THIS TIME, THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | 0158| 1860| E102 |