LUX-DX? INSERTABLE CARDIAC MONITOR
Report
- Report Number
- 2124215-2025-60898
- Event Type
- Injury
- Date Received
- August 29, 2025
- Date of Event
- July 8, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MXD
- UDI-DI
- 00802526607103
- PMA / PMN Number
- K193473
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473, K210608 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INSERTABLE CARDIAC MONITOR (ICM) WAS INSPECTED AND ANALYZED. VISUAL EXAMINATION NOTED NO ANOMALIES. THE CURRENT DRAIN WAS MEASURED AND FOUND TO BE NORMAL. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS
"G4: PMA/510(K) # FIELD ON 3500A FORM IS K193473, K210608 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD."
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED DUE TO SKIN DISCOMFORT AND IT WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). NO NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED DUE TO SKIN DISCOMFORT AND IT WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). NO NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2130495 | LUX-DX? INSERTABLE CARDIAC MONITOR | INSERTABLE CARDIAC MONITOR | MXD | BOSTON SCIENTIFIC CORPORATION | M301 | 143933 | 00802526607103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Unknown | Required Intervention| H |