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

Lot Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 01, 2018, (b)(4).

Event Description

Per the clinic, the patient underwent revision surgery on (b)(6) 2018, in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.No other event or complications that may have contributed to the decision to convert the patient were reported.

• Brand Name: NI
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 7304840
• MDR Text Key: 101231566
• Report Number: 6000034-2018-00450
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR