FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1946120
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20254
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- October 15, 2010
- Report Date
- October 19, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS REPLACED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED, SO IT WILL NOT BE RETURNED FOR ANLAYSIS.
Additional Manufacturer Narrative · 1
AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS SUBSEQUENTLY REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED, AS IT WAS SUSPECTED THAT THIS LEAD WAS FRACTURED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT HIGH, OUT OF RANGE, PACING IMPEDANCE MEASUREMENTS WERE DETECTED ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD. NOISE AND SENSING ISSUES HAVE ALSO BEEN NOTED ON THIS LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Life Threatening| R | 0158| E102 |