FDA Adverse Event
Malfunction
Summary report: N
FINELINE II STEROX
MDR report key: 14640140
·
Received June 8, 2022
Report
- Report Number
- 2124215-2022-20249
- Event Type
- Malfunction
- Date Received
- June 8, 2022
- Date of Event
- May 23, 2022
- Report Date
- June 8, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526060915
- PMA / PMN Number
- P960004/S014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 0
IT WAS REPORTED PRIOR TO A NORMAL DEVICE REPLACEMENT THIS RIGHT VENTRICULAR LEAD EXHIBITED LOW OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THE PATIENT HAD RECEIVED A DUAL CHAMBER PACEMAKER WITH MODIFIED BIVENTRICULAR IMPLANT LEADS CONNECTED BY Y-LEAD ADAPTOR AND THEN CONNECTED TO THE RIGHT VENTRICULAR PORT OF THE DEVICE. THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679870 | FINELINE II STEROX | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4457 | 00802526060915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female |