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 Pain (1994); Burning Sensation (2146)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced heat and pain at the implant site.Subsequently, the patient underwent a revision surgery on (b)(6) 2022 in order to have the internal magnet removed and a cover screw 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: 15263726
• MDR Text Key: 298277042
• Report Number: 6000034-2022-02424
• 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: 08/22/2022,08/01/2022

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: 08/09/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2022
• Distributor Facility Aware Date: 08/01/2022
• Date Report to Manufacturer: 08/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female