MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 3; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 95773

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced pain and magnet extrusion.Subsequently, the patient underwent surgery (date not reported) under general anaesthetic, to explant the magnet.The device remains insitu.

Manufacturer Narrative

This report is submitted on 11 february 2020.

• Brand Name: SP MAGNET 3
• 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
• MDR Report Key: 8265586
• MDR Text Key: 133695632
• Report Number: 6000034-2019-00092
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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: 95773
• Device Catalogue Number: 95773
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention