MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT END USER CASE; COCHLEAR BAHA ATTRACT SYSTEM

Model Number	94125
Health Effect - Clinical Codes	Hearing Impairment (1881); Pain (1994)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on august 14, 2019.
Event or Problem Description
Per the clinic, the patient experienced hearing loss and inability to use baha device due to chronic pain with device use.Implant in suboptimal position for attract type of connection.As per patient request, surgeon performed a baha attract connect replacement surgery on (b)(6) 2019, the attract connect has been changed to connect abutment.

• Brand Name: COCHLEAR BAHA ATTRACT END USER CASE
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 8895620
• Report Number: 6000034-2019-01622
• Device Sequence Number: 13829144
• Product Code: LXB
• UDI-Device Identifier: 09321502027120
• UDI-Public: (01)09321502027120(10)COH1231978
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 08/14/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 94125
• Device Catalogue Number: 94125
• Device Lot Number: COH1231978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2019
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Date Report Sent to FDA: 08/14/2019