FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 16464616
·
Received March 1, 2023
Report
- Report Number
- 2124215-2023-09737
- Event Type
- Malfunction
- Date Received
- March 1, 2023
- Date of Event
- February 23, 2023
- Report Date
- March 23, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526397738
- PMA / PMN Number
- P960006/S005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: H6 FIELD CODE A072202 ADDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THE PACEMAKER SYSTEM EXHIBITED LOW IMPEDANCES OUT OF RANGE ON THIS RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED A CLINIC EVALUATION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THE PACEMAKER SYSTEM EXHIBITED LOW IMPEDANCES OUT OF RANGE ON THIS RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED A CLINIC EVALUATION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517057 | FLEXTEND | IMPLANTABLE LEAD | DTB | BOSTON SCIENTIFIC CORPORATION | 4087 | 311510 | 00802526397738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male |