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 Headache (1880)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced headaches.The baha attract magnet was removed and a baha connect abutment was placed onto the same implant on (b)(6) 2022 under a general anaesthetic.The implant remains in-situ.

Manufacturer Narrative

This report is submitted on november 29, 2022.

• 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: 15874888
• MDR Text Key: 304419534
• Report Number: 6000034-2022-03565
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2022

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 Model Number: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male