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

Model Number	93550
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Infection (4544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on july 5, 2024.
Event or Problem Description
Per the clinic, the patient experienced an infection at implant site.Additional information has been requested but has not been made available as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the patient was administered with topical antibiotics twice on (b)(6) 2024 and (b)(6) 2024 and oral antibiotics twice on (b)(6) 2024 and (b)(6) 2024 (specific durations not reported).
Additional Manufacturer Narrative
Per the clinic, the implant magnet was explanted on (b)(6) 2024 under general anesthesia.Subsequently, the patient was re-implanted with a transcutaneous osia implant system at new site.

• Brand Name: BIM400 IMPLANT MAGNET
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19679274
• Report Number: 6000034-2024-02374
• Device Sequence Number: 17871894
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)122699(17)170430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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: 04/30/2017
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 122699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 05/27/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 11/17/2024; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female