BIM400 IMPLANT MAGNET 93550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for BIM400 IMPLANT MAGNET 93550 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[184239617] Per the clinic, the patient underwent revision surgery on (b)(6) 2020, in order to reposition the internal fixture due to the implant being too close to the pinna, causing the patient pain. The surgery was reported to be unsuccessful and subsequently, the internal magnet was explanted and a cover screw was placed. The patient will continue to be clinically managed by their healthcare provider for future reimplantation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00758
• MDR Report Key: 9857728
• Date Received: 2020-03-19
• Date of Report: 2020-02-25
• Date of Event: 2020-02-20
• Date Facility Aware: 2020-02-25
• Report Date: 2020-03-20
• Date Reported to FDA: 2020-03-20
• Date Reported to Mfgr: 2020-03-20
• Date Added to Maude: 2020-03-19
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIM400 IMPLANT MAGNET
• Generic Name: COCHLEAR BAHA ATTRACT SYSTEM
• Product Code: LXB
• Date Received: 2020-03-19
• Model Number: 93550
• Catalog Number: 93550
• Lot Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Address: KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-19