FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3092590
·
Received May 3, 2013
Report
- Report Number
- 2124215-2013-05203
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- March 9, 2013
- Report Date
- March 11, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- 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 THIS TACHYCARDIA RIGHT VENTRICULAR (RV) LEAD WAS NOT GIVING THERAPY WHEN NEEDED. THIS RV LEAD WOULD UNDERGO A REVISION. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193929 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L| R | N140| 0296| MISMATCH| 4473 |