MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 5, 2020.

Event Description

Per the clinic, the patient experienced issues with retention, sound quality, and skin irritation.The patient underwent revision surgery on (b)(6) 2020, in order to convert the patient to a percutaneous baha implant system.During the procedure, the internal magnet was removed, and an abutment was placed on the internal fixture.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10789591
• MDR Text Key: 214721418
• Report Number: 6000034-2020-03013
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR