MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BIM400 IMPLANT MAGNET; Cochlear Baha Attract System

Model Number	93550
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Expulsion (2933); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Necrosis (1971); Tissue Breakdown (2681); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient presented on (b)(6) 2026 with skin necrosis and exposure of the implant magnet.Subsequently, the patient underwent a surgical procedure including exploration, debridement and the implant magnet was explanted on (b)(6) 2026.
Event or Problem Description
Per the clinic, the patient experienced skin breakdown followed by skin necrosis due to excessive magnet strength.Subsequently, the patient developed an infection at the magnet site.The implant magnet was later explanted (date not reported).Additional information has been requested but remains unavailable as of the date of this report.

• Brand Name: BIM400 IMPLANT MAGNET
• Common Device Name: Cochlear Baha Attract System
• Manufacturer (Section D): Cochlear Bone Anchored Solutions AB; konstruktionsvägen 14; mölnlycke, västergötland 43533 ; SW 43533
• MDR Report Key: 25180807
• Report Number: 6000034-2026-01991
• Device Sequence Number: 18816991
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)146982(17)250420
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026
• Report Date (Section F): 08/26/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/20/2025
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 146982
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 08/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 08/26/2026