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 Pain (1994); Dizziness (2194)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned to manufacturer.

Event Description

Per the clinic, the patient experienced pain, nausea and dizziness with device use; subsequently the patient was hospitalized (date not reported) on four separate occasions.The symptoms did not resolve, resulting in the decision to explant the device.The device was explanted on (b)(6) 2016, it is unknown if there are plans to re-implant the patient with a new device as of the date of this report august 16, 2016.

Manufacturer Narrative

Correction: the initial reporter was the patient, not the reporter recorded on the initial report.(b)(4).

• 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 AMERICAS; 13059 east parkview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5877736
• MDR Text Key: 52162055
• Report Number: 6000034-2016-01561
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

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: BIM400
• Device Catalogue Number: 93550
• Device Lot Number: 90863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/26/2016
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• 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: 56 YR