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

Model Number	87036
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
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
The rhythmia mapping system was selected for use.It was reported that the localization generator was not transmitting data to the signal station.The procedure could not be completed due to this event.No patient complication was reported and it is unknown if patient was sedated at the time of procedure cancellation.The system will not be returned as onsite field service was requested.
Additional Manufacturer Narrative
Correction to d: suspect medical device.Additional information added to b5: describe event or problem, as procedure cancellation occurred prior to patent sedation boston scientific no longer considers the event as reportable.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
The rhythmia mapping system was selected for use.It was reported that the localization generator was not transmitting data to the signal station.The procedure could not be completed due to this event.No patient complication was reported and it is unknown if patient was sedated at the time of procedure cancellation.The system will not be returned as onsite field service was requested.It was further reported that the patient was not sedated at the time of procedure cancellation.

• Brand Name: RHYTHMIA HDX
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; arden hills MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19537862
• Report Number: 2124215-2024-36479
• Device Sequence Number: 15538240
• Product Code: DQK
• UDI-Device Identifier: 08714729972679
• UDI-Public: 08714729972679
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: SP
• PMA/510(K) Number: K162793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 87036
• Device Catalogue Number: 87036
• Device Lot Number: 1000000152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/16/2024
• Date Device Manufactured: 09/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male