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 Erythema (1840); Pain (1994)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced pain and redness at implant site and subsequently was treated with antibiotics (specific date and duration not reported); however, this did not alleviate the problem resulting in a decision to explant the device.The device was explanted on (b)(6) 2022, and it is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2022, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the implant magnet was removed and the osia implant was placed on the internal fixture.

• 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: 13935604
• MDR Text Key: 288084641
• Report Number: 6000034-2022-00900
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)118075(17)220407
• 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,Followup
• Report Date: 05/11/2022,04/11/2022

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: 04/07/2022
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 118075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2022
• Distributor Facility Aware Date: 04/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female