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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 01/01/2010
Event Type  Injury  
Event Description

It was reported by the patient's mother that the vns patient was previously intubated during an unknown procedure. During the intubation, vns stimulation was left on which reportedly resulted in irritation and swelling the vocal cords. The swelling was so severe that when the intubation tube was removed, the patient couldn't breathe and had to be re-intubated and placed on a ventilator. The vns stimulation was then turned off and the swelling reportedly started going down. After three days the patient was taken of the ventilator and was "fine. " the patient's vns was programmed back on. Follow-up with the vns implanting surgeon found no record of any surgery at the reported time was noted. Diagnostics taken on (b)(6) 2010, were within normal limits. Attempts for additional information have been unsuccessful to date.

 
Event Description

The patient's generator was replaced due to normal end of service on (b)(6) 2010. The pulse generator was returned for analysis to the manufacturer, and the module performed according to functional specifications during product analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Additional information was received from the treating cpnp indicating that she does not have access to the records regarding when this event occurred. She suspected sometime in (b)(6) 2011. Since the timeframe is unclear, the event date will be left as 2010. She attributes the vocal cord swelling to intubation and the continued vns stimulation. The only intervention that was reported was the device being temporarily turned off at the time of the event. Prior to the onset of the swelling, the patient was ill with acute viral respiratory illness. The patient does not have a history of similar issues.

 
Manufacturer Narrative

Device available for evaluation, corrected data: the initial report inadvertently did not report that the explanted generator was previously received by the manufacturer. Device evaluated by mfr, corrected data: the initial report inadvertently did not report that the explanted generator was previously evaluated by the manufacturer.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2786736
Report Number1644487-2012-02618
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 09/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/01/2007
Device MODEL Number102
Device LOT Number012704
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2010
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/06/2012
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 TREATMENT DATA
Date Received: 10/14/2012 Patient Sequence Number: 1
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