FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210885
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07467
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- November 1, 2012
- Report Date
- April 24, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN WILL CONTINUE MONITORING. 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 DURING A ROUTINE IN-CLINIC FOLLOW UP, REVIEW OF STORED DEVICE MEMORY REVEALED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS APPROXIMATELY FIVE MONTHS AGO. ALL SUBSEQUENT MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309227 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | T180| E143| 4469| 0180 |