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 Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023 (specific date not reported) for unspecific medical reasons.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced poor performance with the device.The patient was placed under general anesthesia on (b)(6), 2023, in order to convert the patient to a transcutaneous osia implant system.

• 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: 17973182
• MDR Text Key: 326116362
• Report Number: 6000034-2023-03410
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)129883(17)230214
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023,10/17/2023

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: 02/14/2023
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 129883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 10/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male