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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Impairment (1881); Pain (1994)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

This report is filed, january 14, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced poor sound quality and pain with and without device use resulting in the decision to revise to an abutment.Subsequently on (b)(6) 2015 the patient underwent surgery to have the internal magnet removed and an abutment placed.The implanted device remains.

• Brand Name: ATTRACT SYSTEM
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw, CO 2109 ; AS 2109 ; 3037909010
• MDR Report Key: 5368417
• MDR Text Key: 36023496
• Report Number: 6000034-2016-00106
• 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: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: 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
• Patient Age: 35 YR