FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE MRI EL DR
MDR report key: 17485615
·
Received August 9, 2023
Report
- Report Number
- 2124215-2023-42332
- Event Type
- Malfunction
- Date Received
- August 9, 2023
- Date of Event
- June 26, 2023
- Report Date
- August 9, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P150012/S000
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS PACEMAKER RECORDED EPISODES WHERE FAR FIELD R WAVE OVER SENSING IN ATRIAL CHANNEL WAS OBSERVED. PROGRAMMING OPTIONS WERE RECOMMENDED FOR THIS PACEMAKER THAT REMAINS IN SERVICE. MEDICATION ADJUSTMENT MAY BE NECESSARY IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1588615 | ACCOLADE MRI EL DR | IMPLANTABLE PACEMAKER | LWP | BOSTON SCIENTIFIC CORPORATION | L331 | 555179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male |