MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM; LXB

Model Number BIM400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Necrosis Of Flap Tissue (1972)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed june 2, 2016.Device remains implanted.

Event Description

Per the clinic, the patient developed an infection and necrosis of the skinflap, resulting in exposure of the implant magnet.Subsequently, the patient was treated with a course of antibiotics (type and duration unknown).The implanted device remains.There are plans to remove the internal magnet; however, this has yet to occur as of the date of this report, may 31, 2016.

Manufacturer Narrative

(b)(4).Per the clinic, the patient underwent revision surgery on (b)(6) 2016, to explant the internal magnet.The implanted device remains.

• Brand Name: COCHLEAR BAHA ATTRACT SYSTEM
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 435 33, 435 2 2; SW 435 22
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5693769
• MDR Text Key: 46358413
• Report Number: 6000034-2016-01129
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIM400
• Device Catalogue Number: 93550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• 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 Age: 7 YR