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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced pain at abutment site and subsequently the patient underwent revision surgery on (b)(6) 2016, in order to place an internal magnet.

Manufacturer Narrative

Per the clinic, the patient was treated with oral antibiotics to treat the infection at the implant site (date and duration not reported).

• 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 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, CO 43533 ; SW 43533
• Manufacturer Contact: bianca pries ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5995664
• MDR Text Key: 56330341
• Report Number: 6000034-2016-01914
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 93550
• Device Lot Number: 93885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2016
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR