FINELINE II EZ STEROX
Report
- Report Number
- 2124215-2022-32824
- Event Type
- Malfunction
- Date Received
- August 26, 2022
- Date of Event
- August 24, 2022
- Report Date
- September 1, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- PMA / PMN Number
- P960004/S014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
THIS REPORT IS BEING FILED TO UPDATE THE PATIENT IDENTIFIER.
THIS REPORT IS BEING FILED TO UPDATE THE PATIENT IDENTIFIER.
IT WAS REPORTED THAT DURING THE IMPLANT THIS RIGHT ATRIAL (RA) LEAD DID NOT PACE AND HIGH PACING THRESHOLDS WERE SEEN. THE LEAD WAS REPOSITIONED BUT THE OBSERVATIONS DID NOT CHANGE THUS A NEW LEAD WAS USED. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING THE IMPLANT THIS RIGHT ATRIAL (RA) LEAD DID NOT PACE AND HIGH PACING THRESHOLDS WERE SEEN. THE LEAD WAS REPOSITIONED BUT THE OBSERVATIONS DID NOT CHANGE THUS A NEW LEAD WAS USED. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING THE IMPLANT THIS RIGHT ATRIAL (RA) LEAD DID NOT PACE AND HIGH PACING THRESHOLDS WERE SEEN. THE LEAD WAS REPOSITIONED BUT THE OBSERVATIONS DID NOT CHANGE THUS A NEW LEAD WAS USED. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2088963 | FINELINE II EZ STEROX | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4471 | 581111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male |