FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 4131705
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-17292
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 11, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS EXPLANTED DUE TO INSULATION DAMAGE, LEAD BODY DAMAGE AND A CONDUCTOR FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612617 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| R | N119| 4470| 0184| 4542 |