FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 8250485
·
Received January 15, 2019
Report
- Report Number
- 2124215-2019-00415
- Event Type
- Injury
- Date Received
- January 15, 2019
- Date of Event
- March 1, 2018
- Report Date
- January 15, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526531125
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF LESS THAN 20 OHMS, PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS, LOSS OF CAPTURE, POCKET STIMULATION WITH PACING, NOISE, OVERSENSING, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP), AND INAPPROPRIATE SHOCKS. A SURGICAL REVISION WAS PERFORMED, AND THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43095 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0157 | 00802526531125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| L| R |