MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	87042
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that due to a device issue the procedure was cancelled.During a procedure an backpatch was selected for use.When the patient was removed from the procedure table there was no tracking of the catheter on the rhythmia system.The rhythmia mapping specialist (rms) rebooted the workstation and signal station which did not resolve the issue.Replacing the cable and the catheter also did not resolve the issue.Therefore the ablation portion of the procedure was cancelled and the physician proceeded to implant the cardiac resynchronization therapy device in the patient successfully without any patient complications.Additional information revealed that after the case the rms replaced the backpatch and the problem was resolved.

• Brand Name: RHYTHMIA HDX
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10747612
• Report Number: 2134265-2020-14914
• Device Sequence Number: 3060531
• Product Code: DQK
• UDI-Device Identifier: 08714729938682
• UDI-Public: 08714729938682
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 87042
• Device Catalogue Number: 87042
• Device Lot Number: 1000001098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1