FDA Adverse Event
Injury
Summary report: N
EASYTRAK 3 IS-1
MDR report key: 4140431
·
Received October 3, 2014
Report
- Report Number
- 2124215-2014-17610
- Event Type
- Injury
- Date Received
- October 3, 2014
- Date of Event
- September 29, 2014
- Report Date
- June 15, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526420276
- PMA / PMN Number
- P010012/S032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED LOSS OF CAPTURE AND UNDERSENSING. THE PATIENT ALSO EXPERIENCED MUSCLE STIMULATION. AN X-RAY WAS PERFORMED WHERE THE LEAD WAS NOTED TO HAVE DISLODGED. A REVISION PROCEDURE WAS TO BE SCHEDULED FOR SOMETIME IN THE FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619247 | EASYTRAK 3 IS-1 | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | 4548 | 173699 | 00802526420276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Hospitalization| R| L | 0292| 4135| 4548| N160| 4548| 0292| 4135| N160 |