FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 16475670
·
Received March 2, 2023
Report
- Report Number
- 2124215-2023-09963
- Event Type
- Malfunction
- Date Received
- March 2, 2023
- Date of Event
- February 23, 2023
- Report Date
- March 24, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526397721
- 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: CODE REPLACE ON H6 FIELD: A072202.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THE PACEMAKER SYSTEM EXHIBITED LOW IMPEDANCES OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD AND THIS RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED A CLINIC EVALUATION. THIS RA 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 THE RIGHT VENTRICULAR (RV) LEAD AND THIS RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED A CLINIC EVALUATION. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1947444 | FLEXTEND | IMPLANTABLE LEAD | DTB | BOSTON SCIENTIFIC CORPORATION | 4086 | 265387 | 00802526397721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male |