MAUDE Adverse Event Report: COCHLEAR CORP NUCLEUS CI512 WITH CONTOUR ADVANCE ELECTRODE

Device Problems Inadequate Instructions for Healthcare Professional (1319); Nonstandard Device (1420); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Failure of Implant (1924)

Event Date 04/20/2015

Event Type  Other  

Event Description

Pt underwent surgery to replace her left cochlear implant due to device failure/mfr recall.When the child came in to our office for initial activation of her replacement device we discovered a problem.The magnet polarity was flipped; therefore, the standard external equipment would not connect properly to the internal device.We contacted the mfr to assist with troubleshooting measures over the phone.They determined that the internal magnet must be flipped.We notified physician at that time.The physician scheduled the child for an x-ray to review placement of the internal device.After reviewing the x-ray it was determined the internal magnet was placed incorrectly inside the device (mfr defect).We worked with the family and the mfr and were able to obtain an external magnet with reversed polarity so that the child's device can still be activated.No harm done to the pt.With an external work-around, her device is currently functioning properly.This has also occurred on another pt; however, we though it was an isolated event and there was no harm done and work-around from mfr provided.At that time we were instructed to turn the standard magnet around and place it backwards in the device.It is function; however, we have asked the mfr to send their flipped polarity magnet for this pt as well.The mfr should provide physicians with a way to check magnet polarity in the operating room to help prevent this issue from occurring.

Event Description

Add'l info received from reporter on (b)(6) 2015: the hearing implant nucleus ci512 was recalled.The mfr (cochlear corporation) re-released it again this year for use after corrections.The problem is the writing on the new nucleus ci512 device appears to have changed with the "re-release".It appears with the new implant that cochlear corporation flipped the writing.Writing on hearing implants should be standardized among the hearing implant device mfrs.Hearing implant device mfrs would also, as a standardized measure, provide a magnet for the surgeon to use in the operating room so the surgeon can test the polarity of the device in the operating room during surgery.Addendum to prior report is that the device is not a single use device that was preprocessed or reused on a pt.

• Brand Name: NUCLEUS CI512 WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS CI512 WITH CONTOUR ADVANCE ELECTRODE
• Manufacturer (Section D): COCHLEAR CORP; centennial CO 80111
• MDR Report Key: 4799564
• MDR Text Key: 18889200
• Report Number: MW5042819
• Device Sequence Number: 1
• Product Code: MCM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR