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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 08/22/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing pain in his neck and arms. Diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient had recently experienced a drop seizure which may have affected the patient¿s device. Following the drop seizure, the patient began experiencing an increase in seizures. During stimulation on-times, the patient experienced epiglottis contractions, itching around the neck, spasms of the left arm and pain the left arm. The patient stated that he was able to feel the electrical pulse from his device travel through the lead. X-rays were taken and no lead breaks were found; however, the physician stated that the electrodes appeared misaligned on the patient¿s nerve and suspected a partial detachment or shift of the electrodes. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. It was noted that the electrode alignment on the vagus nerve did not follow a straight line. Based on the images provided, the cause of the reported events cannot be determined. No known interventions have occurred to date.

 
Event Description

It was reported that the patient's surgery was cancelled because device diagnostics were within normal limits. The generator was programmed back on.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4113291
Report Number1644487-2014-02442
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number102
Device LOT Number202085
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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