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

Model Number 93550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection and discharge at the incision site, and was treated with steroids and antibiotics (duration and date not reported).The implanted device remains.Explantation is planned but has not taken place at the time of this report.

Event Description

It was reported that the internal magnet was explanted on (b)(6) 2020.

Manufacturer Narrative

It was reported that the internal magnet was explanted on (b)(6) 2020.This report is submitted on 10 february 2021.

• 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: 11032586
• MDR Text Key: 222283121
• Report Number: 6000034-2020-03656
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/10/2021,01/18/2021

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 Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 130947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2021
• Distributor Facility Aware Date: 01/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention