FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 4166607
·
Received October 13, 2014
Report
- Report Number
- 2124215-2014-17933
- Event Type
- Injury
- Date Received
- October 13, 2014
- Date of Event
- September 26, 2014
- Report Date
- September 30, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES, LOSS OF CAPTURE (LOC) AND INAPPROPRIATE SHOCKS. A CHEST X-RAY CONFIRMED A CONDUCTOR FRACTURE. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645955 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 0181| T175 |