MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Meningitis (2389)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 27, 2021.

Event Description

Per the clinic, the patient was hospitalized (specific date and duration not reported) due to meningitis.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

It has now been reported that the meningitis was not device related.The patient was born in 1955 (exact date unknown) and had been implanted in 2008.She had multiple internal bacteria as well as meningitis.She died from a cardiac arrest.This report is submitted on january 7, 2022.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA CONNECT 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: roberta loveday ; 1 university avenue; no. 8 jalan kerinchi,; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 13086043
• MDR Text Key: 282774736
• Report Number: 6000034-2021-04118
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121317
• 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
• Report Date: 01/06/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/26/2021
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/06/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Female