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

Catalog Number 92129

Device Problem Missing Value Reason (3192)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report is filed, february 2, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced a loose internal magnet.Subsequently on (b)(6)2016, the patient underwent revision surgery to tighten the internal magnet.During the procedure, it was reported that there was a benign cyst located between the skull and internal magnet.The cyst was fluid filled and believed to be putting pressure on the internal magnet, loosening it.The cyst was drained.The implanted device remains.As of report on (b)(6) 2016, the site is healing well with no signs of the cyst returning.

• Brand Name: ATTRACT SYSTEM
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5405947
• MDR Text Key: 37333404
• Report Number: 6000034-2016-00181
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 92129
• Device Lot Number: 173532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention