MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 2; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 95771

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is filed on november 24, 2016.(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced pain and breakdown of skin at magnet site, and was treated with topical and oral antibiotics (date and duration not reported).The issue could not be resolved; subsequently the patient underwent revision surgery to remove the internal magnet.Clinical management is ongoing.

• Brand Name: SP MAGNET 2
• 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
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east parkview avenue; centennial CO 80111
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6126581
• MDR Text Key: 60842393
• Report Number: 6000034-2016-02337
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/08/2016

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: 95771
• Device Catalogue Number: 95771
• Device Lot Number: 112772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2016
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/23/2016
• 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