FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3904254
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-07782
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- September 27, 2013
- Report Date
- April 7, 2014
- Manufacturer
- GUIDANT PUERTO RICO BV
- 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 HIGH SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THE SYSTEM CONTINUED TO EXHIBIT HIGH SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE AND LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384610 | ENDOTAK RELIANCE | NVY | GUIDANT PUERTO RICO BV | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | F140 |