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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD . NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM; MHE
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COCHLEAR LTD . NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM; MHE Back to Search Results
Model Number ABI24M
Device Problem No Device Output (1435)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 07/01/2015
Event Type  malfunction  
Event Description
Per the clinic, the patient experienced a loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Per the clinic, the device was explanted (b(6) 2015, and the patient was reimplanted with a new device during the same surgery.This report is filed april 1, 2016.
 
Manufacturer Narrative
Correction; the common device name and product name is mhe; and not mcm as previously reported.
 
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Brand Name
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Type of Device
MHE
Manufacturer (Section D)
COCHLEAR LTD .
14 mars rd
po box 629
lane cove, nsw 2066
AS  2066
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key4889476
MDR Text Key16495105
Report Number6000034-2015-01403
Device Sequence Number1
Product Code MHE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
000015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Audiologist
Type of Report Initial,Followup,Followup
Report Date 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberABI24M
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/25/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 MO
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