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

Model Number 93550

Device Problem Migration (4003)

Patient Problem Hearing Impairment (1881)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the surgeon, it was reported that the patient experienced a dislodged magnet.

Manufacturer Narrative

It was reported the device was explanted on (b)(6) 2018 and the patient was reimplanted with another device.This report is submitted on march 29, 2018.

Manufacturer Narrative

This report is filed on may 05, 2018.(b)(4).

Manufacturer Narrative

Per the surgeon, the magnet was replaced on (b)(6) 2018.This report has intentionally been marked as follow-up # 3; instead of follow-up #1 as duplicates with follow-up #1 and follow-up #2 have inadvertently been submitted previously.This report is submitted on january 23, 2019.

• 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: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7380497
• MDR Text Key: 129577495
• Report Number: 6000034-2018-02355
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 11/16/2018; 01/08/2019
• Supplement Dates FDA Received: 03/28/2018; 05/10/2018; 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2005
• 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
• Patient Age: 13 YR