MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA AMBITION X

Model Number	INGENIA AMBITION X
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear Pain (4812)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A clinical assessment performed based on the currently available information within the complaint record.The customer states that a patient with a cochlear implant reported pain upon entering the mri suite.The patient was removed immediately and there were no health consequences to the patient.The reported pain is categorized as a minor injury and does not meet the criteria for a serious injury as no health consequences was documented to have occurred.Out of an abundance of caution we have concluded that this is a reportable event.This event is under investigation and a supplemental report will be submitted upon investigation completion.
Additional Manufacturer Narrative
Conclusion: the mri system was checked and confirmed to operate within product specifications and according to guidelines provided by the manufacturer of the implant.Any further investigation will be done by the manufacturer of the implant.At this time no further investigation will be conducted by philips.It was confirmed the patient¿s mother moved the implant back into the appropriate position.The patient did not receive additional medical intervention, harm, or loss of hearing related to this reported event.
Additional Manufacturer Narrative
Correction to the conclusion regarding the patient, the implant did not become dislodged nor need to be put back into appropriate position.Updated conclusion: the customer states that despite following all the safety recommendations of the implant manufacturer, and applying the relevant limitations in the scanwise tool, a patient with a cochlear implant reported pain upon entering the mri suite.The patient was removed immediately and there were no health consequences to the patient.The reported pain is categorized as a minor injury and does not meet the criteria for a serious injury as no health consequences was documented to have occurred.Investigation was performed -logfile analysis and testing of the mri system found no indications that the mri system malfunctioned or that use error had occurred; the mri system is operating to product specifications.In addition, the customer confirmed that the cochlear¿s nucleus implants mri safety checklist and guidelines were followed.Based on this conclusion, this event is considered not reportable.The manufacturer of the implant is aware of this event.
Additional Manufacturer Narrative
Correction to the conclusion regarding the patient, the implant did not become dislodged nor need to be put back into appropriate position.Updated conclusion: the customer states that despite following all the safety recommendations of the implant manufacturer, and applying the relevant limitations in the scanwise tool, a patient with a cochlear implant reported pain upon entering the mri suite.The patient was removed immediately and there were no health consequences to the patient.The reported pain is categorized as a minor injury and does not meet the criteria for a serious injury as no health consequences was documented to have occurred.Investigation was performed -logfile analysis and testing of the mri system found no indications that the mri system malfunctioned or that use error had occurred; the mri system is operating to product specifications.In addition, the customer confirmed that the cochlear¿s nucleus implants mri safety checklist and guidelines were followed.Based on this conclusion, this event is considered not reportable.The manufacturer of the implant is aware of this event.05-sep-2024 correction was made to the dat received by mfg.

• Brand Name: INGENIA AMBITION X
• Common Device Name: INGENIA AMBITION X
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16847139
• Report Number: 3003768277-2023-02614
• Device Sequence Number: 15347634
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K18479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2024

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: INGENIA AMBITION X
• Device Catalogue Number: 781356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 04/17/2023; 04/17/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/20/2023; 07/26/2023; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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