MAUDE Adverse Event Report: COCHLEAR LIMITED BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 11, 2021.

Event Description

Per the clinic, the patient experienced infection and subsequently was treated with topical antibiotics (specific date and duration not reported) however, the issue did not resolve.The patient developed skin flap necrosis resulting in the magnet being exposed.The patient was placed under general anesthesia on (b)(6) 2021, in order to explant the device.It is unknown if there are plans to reimplant the patient as of the date of this report.

Manufacturer Narrative

Correction for this report : part d (device details).

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 12305761
• MDR Text Key: 265972697
• Report Number: 6000034-2021-02394
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 93884
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention