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

Model Number 93550

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Increased Sensitivity (4538)

Event Date 01/18/2021

Event Type  Injury  

Event Description

Per the clinic, the patient experienced issues with sensitivity and retention at the implant magnet site, following a previous soft tissue reduction (specific date not reported).The patient was placed under general anesthesia on (b)(6) 2021, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the abutment was removed and an 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; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 11318693
• MDR Text Key: 231575912
• Report Number: 6000034-2021-00407
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)126645(17)230125
• 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: 02/12/2021,01/18/2021

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: 01/25/2023
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 126645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Distributor Facility Aware Date: 01/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR