MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDx; computer, diagnostic, programmable

Model Number	M004RA71010
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete udi is not available for this device.Once the cables are removed from their packaging it is no longer possible track the lot# for the device so specific device information cannot be obtained from the facility.
Event or Problem Description
It was reported that the magnetic location was lost and catheter could not be visualized while using a localization generator cable, additionally error 1105-2 and 1113-2 were displayed.Picture provided showed error code 1318.No patient complications occurred.Cases were postponed until replacement.There is not any indication if the device will be returned.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: RHYTHMIA HDx
• Common Device Name: computer, diagnostic, programmable
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25117981
• Report Number: 2124215-2026-24940
• Device Sequence Number: 13348949
• Product Code: DSA
• UDI-Device Identifier: 08714729938545
• UDI-Public: (01)08714729938545
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K162793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: M004RA71010
• Device Catalogue Number: M004RA71010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 08/14/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown