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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/06/2013
Event Type  Injury  
Event Description

It was reported that the patient was experiencing spasms of the sternocleidomastoid muscle with device stimulation which was causing the patient to experience head deviations which resulted in airway obstruction. It was reported that the patient used the magnet to disable the device and that the spasms resolved for about 10 minutes, but then started back up. It was reported that it is unclear if the magnet moved off the device because the physician was not present at this time. The patient was seen by the physician at the hospital and the device was programmed off. The physician indicated that it was unclear whether or not the patient's accessory nerve was being stimulated to cause this or whether there is current leakage to the muscle. Attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3329805
Report Number1644487-2013-02606
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number102
Device LOT Number016488
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/08/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/06/2013 Patient Sequence Number: 1
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