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

Model Number 93550

Device Problem Expulsion (2933)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on nov 16, 2021.

Event Description

Per the clinic, the patient experienced an extrusion of the magnet through the skin.The implant remains in-situ.There are plans to surgically repair the site.

Event Description

Per the clinic, the patient experienced skin necrosis (date not reported) at implant site.

Event Description

Per the clinic, the patient underwent a skin revision surgery on (b)(6) 2021.

• 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 3 3; SW 435 33
• MDR Report Key: 12817453
• MDR Text Key: 280801853
• Report Number: 6000034-2021-03494
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2022,12/29/2021

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: 07/10/2023
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 130944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2022
• Distributor Facility Aware Date: 12/29/2021
• Date Report to Manufacturer: 12/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/28/2021; 01/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female