MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-Dx? Insertable Cardiac Monitor; Cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	M301
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field g4 premarket/510k, from section g all manufacturers, contains both documents k193473 and k210608 whose character limit prevented both entries from the field.
Event or Problem Description
It was reported that the patient with this insertable cardiac monitor (icm) indicated that the doctor sent them into emergency surgery following a heart tilt table test for a pacemaker.The surgeon put an icm instead, but this icm never worked right.The icm was finally explanted as it never took readings.No new icm was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this insertable cardiac monitor (icm) indicated that the doctor sent them into emergency surgery following a heart tilt table test for a pacemaker.The surgeon put an icm instead, but this icm never worked right.The icm was finally explanted as it never took readings.No new icm was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.G4: pma/510(k) # field on 3500a form contains an additional code k210608; reported here as it exceeded character limit for designated field.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: LUX-Dx? Insertable Cardiac Monitor
• Common Device Name: Cardiac resynchronization therapy defibrillator (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25884590
• Report Number: 2124215-2026-39028
• Device Sequence Number: 10124520
• Product Code: MXD
• UDI-Device Identifier: 00802526607103
• UDI-Public: (01)00802526607103(17)240308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/08/2024
• Device Model Number: M301
• Device Catalogue Number: M301
• Device Lot Number: 162496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown