FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2153632
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06521
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 10, 2011
- Report Date
- April 10, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND THE THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED. INVESTIGATION IS COMPLETE TO DATE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DETECTED NOISE ON THIS RIGHT VENTRICULAR LEAD. THE NOISE WAS OVERSENSED WHICH RESULTED IN UNNECESSARY SHOCKS. DURING A REVISION PROCEDURE IT WAS DISCOVERED THE LEAD WAS FRACTURED AND APPEARED TO BE ISOLATED TO THE LEAD TIP. THE PHYSICIAN FELT THIS WAS LIKELY DUE TO AXILLARY VENOUS ACCESS SITE NOT A LEAD DEFECT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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 | 75 YR | Required Intervention | T177| 0185 |