LUX-DX? INSERTABLE CARDIAC MONITOR
Report
- Report Number
- 2124215-2025-27599
- Event Type
- Injury
- Date Received
- April 30, 2025
- Date of Event
- February 24, 2025
- Report Date
- February 10, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MXD
- UDI-DI
- 00802526607103
- PMA / PMN Number
- K193473
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT. AS OF TODAY, REQUESTED INFORMATION HAS NOT BEEN RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. FIELD G4 PREMARKET/510K FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS INSPECTED AND ANALYZED. VISUAL EXAMINATION NOTED NO ANOMALIES. IT WAS NOTED THE ICM COULD NOT BE COMMUNICATED WITH. STORED LATITUDE DATA WAS REVIEWED, ASSESSMENT OF DATA FOUND NORMAL BATTERY DEPLETION, NO FAULTS WERE NOTED. LONGEVITY CALCULATIONS CONFIRMED THE DEVICE LASTED AS LONG AS EXPECTED. NO COMMUNICATION COULD BE ESTABLISHED DUE TO THE LOW BATTERY VOLTAGE, CONSISTENT WITH NORMAL BATTERY DEPLETION. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. FIELD G4 PREMARKET/510K FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD.
FIELD G4 PREMARKET/510K FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD. THIS REPORT IS ALSO BEING SUBMITTED TO CORRECT THE EVALUATION METHOD CODE (FIELD H6) AND EVALUATION RESULT CODE (FIELD H6) FROM SECTION H, DEVICE MANUFACTURERS ONLY.
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS EXPLANTED FROM THE PATIENT DUE TO OTHER OBSERVATION OR COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE HAS BEEN RETURNED.
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS EXPLANTED FROM THE PATIENT DUE TO OTHER OBSERVATION OR COMPLICATION. ADDITIONAL INFORMATION FROM BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATES THIS ICM DEVICE WAS EXPLANTED DUE TO BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE HAS BEEN RETURNED.
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE WAS EXPLANTED FROM THE PATIENT DUE TO OTHER OBSERVATION OR COMPLICATION. ADDITIONAL INFORMATION FROM BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATES THIS ICM DEVICE WAS EXPLANTED DUE TO BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE HAS BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032530 | LUX-DX? INSERTABLE CARDIAC MONITOR | INSERTABLE CARDIAC MONITOR | MXD | BOSTON SCIENTIFIC CORPORATION | M301 | 117024 | 00802526607103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Hospitalization| R |