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

Model Number INGENIA AMBITION X

Device Problem Migration (4003)

Patient Problems Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported there was a cochlear implant displacement in a 9 year old male patient scanned on a mr amition x.The customer reported "hat despite following all the safety recommendations of the implant manufacturer, and applying the relevant limitations in the scanwise tool, the patient reported a lot of ear pain after performing a couple of image acquisitions.Accordingly, patient had to be removed from the mri room quickly.Implant displacement was confirmed, and intervention was required to correct the displacement.Based on this information we are considering this to be a reportable event this event is under investigation and a supplemental report will be submitted upon investigation completion.

Manufacturer Narrative

Fields within the emdr have been updated to reflect investigation outcome it was reported there was a cochlear implant displacement in a 9-year-old male patient scanned on a mr amition x.The customer reported "that despite following all the safety recommendations of the implant manufacturer, and applying the relevant limitations in the scanwise tool, the patient reported a lot of ear pain after performing a couple of image acquisitions.Accordingly, patient had to be removed from the mri room quickly.Implant displacement was confirmed, and the patients mother moved the implant back into the appropriate position.There was no additional medical intervention, harm, or loss of hearing related to this reported event.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.

Event Description

It was reported there was a cochlear implant displacement in a 9-year-old male patient scanned on a mr amition x.The customer reported "that despite following all the safety recommendations of the implant manufacturer, and applying the relevant limitations in the scanwise tool, the patient reported a lot of ear pain after performing a couple of image acquisitions.Accordingly, patient had to be removed from the mri room quickly.Implant displacement was confirmed, and the patients mother moved the implant back into the appropriate position.There was no additional medical intervention, harm, or loss of hearing related to this reported 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: 16835830
• MDR Text Key: 314217444
• Report Number: 3003768277-2023-02589
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 07/26/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Male