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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 02/18/2015
Event Type  Injury  
Event Description

It was reported that the patient underwent generator and lead replacement due to an infection. It was reported that the lead was rejected and that it is believed that the infection was caused by a bacteria that the patient brought to the operating room. Cultures showed staphylococcus aureus. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. Surgical notes indicate that the wound dehiscence is suspected to be caused by hypoproteinemia from neurological deterioration of the patient as the patient will not eat solid foods.

 
Event Description

Analysis of the lead was completed on 04/02/2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the 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. Analysis of the generator was completed on 04/06/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key4636128
Report Number1644487-2015-04258
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2017
Device MODEL Number304-20
Device LOT Number3765
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/11/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2013
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: 03/26/2015 Patient Sequence Number: 1
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