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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR AMERICAS NUCLEUS; COCHLEAR IMPLANT
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COCHLEAR AMERICAS NUCLEUS; COCHLEAR IMPLANT Back to Search Results
Model Number CI24RE
Device Problems Electromagnetic Interference (1194); Labelling, Instructions for Use or Training Problem (1318); Electromagnetic Compatibility Problem (2927)
Patient Problem Pain (1994)
Event Date 11/09/2016
Event Type  malfunction  
Event Description
Patient scheduled for mri left knee.He has a cochlear implant in his right ear.Model ci24re.Compatible up to 1.5t and no higher.External portion was removed and a head splint was placed with "splints" over implant.Patient was placed in magnet but prior to starting the scout squeezed the emergency ball saying that the implant was "pulling" and it was hurting him.Pulled patient out immediately and called the physician on call.Radiologist was in agreement to cancel mri.We reviewed the "mri for nucleus® implant recipients radiographer's instructions" from the manufacturer.Technologists had read and followed the instructions carefully before starting the exam.
 
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Brand Name
NUCLEUS
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
COCHLEAR AMERICAS
13059 e. peakview ave.
centennial CO 80111
MDR Report Key6218282
MDR Text Key63737407
Report Number6218282
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCI24RE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2016
Event Location Hospital
Date Report to Manufacturer12/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
MRI SCANNER; NO OTHER THERAPIES
Patient Outcome(s) Other;
Patient Age15 YR
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