FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3052517
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-03914
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- January 10, 2013
- Report Date
- February 27, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 NOISE WAS OVERSENSED ON THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN GREATER THAN TWO SECONDS OF PACING INHIBITION. THE PATIENT WAS NOT SYMPTOMATIC AT THE TIME OF PACING INHIBITION. THE NOISE WAS NOT ABLE TO BE REPRODUCED. THE SENSITIVITY WAS REPROGRAMMED TO RESOLVE THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154924 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |