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

Model Number INGENIA AMBITION X

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 04/17/2023

Event Type  malfunction  

Event 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.

Event Description

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.

Manufacturer Narrative

Updated fields within emdr based on investigation 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.

• Brand Name: INGENIA AMBITION X
• Type of Device: 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: 16848080
• MDR Text Key: 314325086
• Report Number: 3003768277-2023-02617
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K18479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1