FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2172867
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10220
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 10, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS ABANDONED, THEREFORE BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE AN OPEN CIRCUIT WARNING WAS RECEIVED FOR SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ON THE RIGHT VENTRICULAR LEAD. ALL VECTORS WERE TRIED, BUT STILL HIGH IMPEDANCE MEASUREMENTS PERSISTED. AN ADEQUATE LEAD AND HEADER CONNECTION WAS VERIFIED SEVERAL TIMES. AS THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS COULD NOT BE DETERMINED, THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | T165| 0185| 0184| MISMATCH| E110 |