FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213039
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10291
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 13, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. REVIEW OF STORED DEVICE MEMORY REVEALED THAT ALL SUBSEQUENT MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314346 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | 0184| 4470| E110 |