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

Model Number 93550

Device Problem Use of Device Problem (1670)

Patient Problem Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient reportedly developed necrosis of the skin flap under the magnet.Per recommendations of the physician, the patient discontinued use of the processor, and the necrosis reportedly began to heal.On (b)(6) 2017, the patient underwent revision surgery to remove the internal magnet and place an abutment on the implanted fixture, converting the patient to a subcutaneous baha implant system.

Manufacturer Narrative

The reported adverse event is associated with a product that was not returned, or was not made available for analysis.The manufacturer investigation was based on the available clinical information.The reported issue is a known medical complication and no specific device analysis is deemed necessary at this time.Skin breakdown or necrosis at the magnet site can occur with usage of a too strong magnet or/in combination with too long daily use of the sound processor.Issues can often be resolved through equipment troubleshooting e.G.Changing type of magnet or clinical case management.There are six different magnet sizes/strengths available.(b)(4).

• 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 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7039643
• MDR Text Key: 92283205
• Report Number: 6000034-2017-02032
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)119736(17)220410
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2022
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 119736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• 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