MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM; PGQ

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Pain (1994); Swelling (2091)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed on august 17, 2016 by cochlear limited on behalf of cochlear americas.(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient developed a wound infection and experienced pain at the implant incision line.Subsequently, on (b)(6) 2016, the patient was hospitalized for a duration of two days.A ct scan confirmed swelling and cellulitis of soft tissue, and cultures returned positive for infection.During the admission, the patient was administered with iv antibiotics and a wound abscess was drained.Following discharge, the patient was treated with oral antibiotics, twice daily, for a duration of 4 weeks.The wound has reported to have improved, and clinical management of the patient is ongoing.

• Brand Name: NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
• Type of Device: PGQ
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial CO 80111
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5881403
• MDR Text Key: 52273583
• Report Number: 6000034-2016-01648
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 08/04/2016

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: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2016
• Device Age: 1 YR
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/16/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR