MAUDE Adverse Event Report: COCHLEAR LIMITED BRISBANE NUCLEUS PROF CONTOUR ADV. COCHLEAR IMPLANT; MPLANT, COCHLEAR

Model Number P774600

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

During planned exchange of cochlear implant, the new implant's nrt's (neural response telemetry) were noted to be compromised to significantly less than optimal.The intended replacement device was then removed/not implanted.Fda safety report id #(b)(4).

• Brand Name: NUCLEUS PROF CONTOUR ADV. COCHLEAR IMPLANT
• Type of Device: MPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED BRISBANE
• MDR Report Key: 15470792
• MDR Text Key: 300653352
• Report Number: MW5112236
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: P774600
• Device Catalogue Number: P774600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White