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 Headache (1880); Skin Inflammation/ Irritation (4545)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Per the clinic, the patient was placed under general anaesthesia on (b)(6) 2021, to undergo an explant due to headaches and skin irritations.The patient was reimplanted with another cochlear device at a new site in the same surgery.

• 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: 12243599
• MDR Text Key: 264047828
• Report Number: 6000034-2021-02254
• Device Sequence Number: 1
• Product Code: LXB
• 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: 07/29/2021,07/09/2021

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 Model Number: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Distributor Facility Aware Date: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2021
• 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: 50 YR