FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210275
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07717
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 18, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PATIENT STATED THEY BELIEVED THEY WERE CLOSE TO A SECURITY GATE AT THE TIME OF THE OUT-OF-RANGE (OOR) READING. THE PATIENT WAS INTERROGATED AND EVERYTHING CHECKED OUT FINE, NO PLANS FOR INTERVENTION. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310108 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | N160| 0296| 4034| 4054| 4593| S601| 1276 |