MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM; LXB

Model Number BIM400

Device Problem Extrusion (2934)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The date of initial implantation is unknown at the time of this report.This report is submitted on september 23, 2016, by cochlear limited on behalf of cochlear americas.(b)(4).Magnet not received by manufacturer.

Event Description

Per the clinic, the patient experienced extrusion of the internal magnet.Subsequently, revision surgery was performed on (b)(6) 2016, to remove the magnet.During the procedure, an abutment was placed on the fixture.The implanted device remains.

• Brand Name: COCHLEAR BAHA ATTRACT SYSTEM
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east parkview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5972187
• MDR Text Key: 55420840
• Report Number: 6000034-2016-01855
• 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
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIM400
• Device Catalogue Number: 94336
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/02/2016
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention