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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 03/05/2014
Event Type  Death  
Event Description

It was reported that the patient passed away from an unknown reason. It was reported that the device was explanted and would be sent to manufacturer for analysis. The medical examiner indicated that the patient's vagus nerve was explanted with the lead attached to avoid damaging the lead electrodes. The relationship between vns and the death is known. The generator and lead were returned for analysis. The reason for explant was reported as sudden unexpected death with recent history of myocardial infarct (non-ischemic) and possible arrhythmia. The generator analysis was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The lead analysis was completed on (b)(6) 2014. The slice marks found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. The marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. During the visual analysis the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white and (-) green electrode ribbons from coming in contact with the vagus nerve. With the exception of the observed tissue-covered (+) white and (-) green electrodes the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.

 
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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 Key3738321
Report Number1644487-2014-00954
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/12/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2008
Device MODEL Number102
Device LOT Number015168
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/12/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2006
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: 04/10/2014 Patient Sequence Number: 1
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