MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUX-Dx II+?; Insertable Cardia Monitor

Model Number	M312
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an insertable cardiac monitor (icm) indicated an eos (end of service) condition during preparation for implant.The insertable cardiac monitor had been enrolled but was not implanted, and an alternate insertable cardiac monitor was used instead.Technical services requested return of the affected insertable cardiac monitor for evaluation; however, the hospital retained and subsequently discarded the insertable cardiac monitor, making product analysis unavailable.The representative later confirmed that the insertable cardiac monitor successfully transmitted a remote report prior to disposal.No patient impact occurred because the insertable cardiac monitor was not implanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that an insertable cardiac monitor (icm) indicated an eos (end of service) condition during preparation for implant.The insertable cardiac monitor had been enrolled but was not implanted, and an alternate insertable cardiac monitor was used instead.Technical services requested return of the affected insertable cardiac monitor for evaluation; however, the hospital retained and subsequently discarded the insertable cardiac monitor, making product analysis unavailable.The representative later confirmed that the insertable cardiac monitor successfully transmitted a remote report prior to disposal.No patient impact occurred because the insertable cardiac monitor was not implanted.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific and as a result, laboratory analysis could not be conducted.Device history record review: 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.Investigation conclusion: 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 II+?
• Common Device Name: Insertable Cardia Monitor
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50733404
• Report Number: 2124215-2026-48700
• Device Sequence Number: 21498338
• Product Code: MXD
• UDI-Device Identifier: 00802526620706
• UDI-Public: (01)00802526620706(17)271021
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M312
• Device Catalogue Number: M312
• Device Lot Number: 189671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 05/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Unknown