MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC MRQD309040915

Model Number	MRQD309040915
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 a patient was taken to complete a mri procedure.  the section of the non-mri-conditional cabling labeled "mr unsafe" attached to rhythmlink part number mrqd309040915 was not disconnected as required by the instructions for use and remained attached to the patient during the mri, resulting in two burns from the non-mri conditional cabling.

• Brand Name: MRQD309040915
• Common Device Name: MRQD309040915
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first street south ext; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first street south ext; columbia, SC 29209 ; 8032521111
• MDR Report Key: 23596035
• Report Number: 1067162-2025-00007
• Device Sequence Number: 9337404
• Product Code: GXY
• UDI-Device Identifier: 10816312026716
• UDI-Public: 10816312026716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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
• Device Model Number: MRQD309040915
• Device Catalogue Number: MRQD309040915
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown