FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3223548
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10048
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 20, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- 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 DISPLAYED LOW SHOCK IMPEDANCE MEASUREMENT OF 0 OHMS WHICH WAS DETECTED VIA PATIENT'S REMOTE MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL EXPOSURE TO ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE AND MEASUREMENT COULD BE FALSE. TS REVIEWED IMPEDANCE RECORDS AND ALL WERE STABLE EXCEPT WITH THIS EVENT. THE PATIENT WAS SCHEDULED FOR A DEVICE CHECK. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323999 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | 338171| N119| 4592| 1388T| E030| 0185 |