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  

Manufacturer Narrative

The reported adverse event is associated with a returned device; however, insufficient clinical information was provided by the clinic which made it impossible to establish the root cause of the issue.Hence, no specific device analysis is deemed necessary at this time.Should more information be made available at a later date, the decision could be reassessed.This report is submitted on october 20, 2023.

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.

Manufacturer Narrative

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.This report is submitted on november 28, 2023.

• 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: nabila zahari ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17973058
• MDR Text Key: 326116423
• Report Number: 6000034-2023-03409
• 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
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male