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

Model Number 93550

Device Problem Expulsion (2933)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 18, 2022.

Event Description

Per the clinic, the patient experienced an exposure of the implant magnet and was subsequently treated with oral antibiotics (date not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2022 in order to perform a skin revision surgery and the device was explanted.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Skin breakdown or necrosis at the magnet site can occur with usage of a too strong magnet or/in combination with too long daily usage periods of the sp.The patient often has numbness at the implant site after surgery which can explain why the recipient does not feel that skin becomes irritated.Issues can often be resolved through equipment troubleshooting e.G.Changing to a weaker magnet and/or use the sound processor magnet with a softwear pad.There are six different magnet sizes/strengths available.(#1 being the weakest, #6 being the strongest).This report is submitted on august 23, 2022.

Manufacturer Narrative

Per the clinic, the patient experienced necrosis.This report is submitted on august 23, 2022.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15036839
• MDR Text Key: 296041985
• Report Number: 6000034-2022-02051
• 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
• Report Date: 08/05/2022

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: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/17/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 08/05/2022
• Supplement Dates FDA Received: 08/23/2022; 08/24/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female