FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1873961
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17963
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 30, 2010
- Report Date
- September 1, 2010
- 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
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS ON THE COMMODE AND RECEIVED A SHOCK DUE TO NOISE ON THE RV CHANNEL. THE NOISE WAS UNABLE TO BE REPRODUCED WITH ISOMETRICS. THE PATIENT WAS LATER UPGRADED TO A BI-VENTRICULAR DEVICE DUE TO DISEASE PROGRESSION. DURING THIS PROCEDURE, THE PACE\SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED DUE TO QUESTIONABLE SENSING ISSUES. 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 | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | E030| 0158| 4136 |