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

Model Number 93550

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 11/03/2023

Event Type  Injury  

Event Description

Per the clinic, the implant magnet was explanted on (b)(6) 2023, due to pain at the implant site.There are no plans to reimplant the patient with a new device as of the date of this report.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 18289162
• MDR Text Key: 329993079
• Report Number: 6000034-2023-03943
• 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: Other
• Type of Report: Initial
• Report Date: 12/08/2023,11/16/2023

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: 12/07/2021
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 117604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2023
• Distributor Facility Aware Date: 11/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female