FDA Adverse Event
Malfunction
Summary report: N
ACUITY? X4 SPIRAL L
MDR report key: 23709188
·
Received December 3, 2025
Report
- Report Number
- 2124215-2025-88996
- Event Type
- Malfunction
- Date Received
- December 3, 2025
- Date of Event
- June 27, 2025
- Report Date
- December 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526524592
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF AN ATRIAL SIGNAL ON THE LEFT VENTRICULAR (LV) LEAD. THIS RESULTED IN THE INHIBITION OF THE LV PACE. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS AND RECOMMENDED TO HAVE AN X RAY REVISION OF THE LEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2787526 | ACUITY? X4 SPIRAL L | IMPLANTABLE LEAD | LWP | BOSTON SCIENTIFIC CORPORATION | 4677 | 845503 | 00802526524592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female |