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

Model Number 93550

Device Problem Extrusion (2934)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

This report is submitted by cochlear limited (manufacturer) on behalf of cochlear americas.(b)(4).This report is filed october 5, 2016.Implanted device remains.

Event Description

Per the clinic, the patient experienced skin flap breakdown resulting in the extrusion of the device.Subsequently, the patient was treated with topical antibiotics.There are plans to explant the magnet and close the implant site; however, this has not occurred as of the date of this report, (b)(6) 2016.

Manufacturer Narrative

Correction: the correct model number is: 93550; the correct catalog # is: 93550; the correct lot # is: 107243; the correct brand name is: bim400 implant magnet.Per the patient's audiologist, the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet.During the procedure, an abutment was placed on the fixture.This report is submitted january 18, 2017.

• 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 33, ; SW
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111, us
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 5998905
• MDR Text Key: 56441910
• Report Number: 6000034-2016-01951
• 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,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• 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: 107243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No
• 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