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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 11/06/2014
Event Type  Injury  
Event Description

The explanted product was received by the manufacturer for analysis.

 
Event Description

Analysis was completed on the explanted products. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions 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 portions of the device which may have contributed to the stated complaint. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

It was later reported that the patient¿s lead was extruding after the incision opened on (b)(6) 2015. The patient was seen in the emergency room and evaluation by the surgeon confirmed that the vns explant was warranted. The hospital reported that the generator and lead were explanted on (b)(6) 2015 due to infection.

 
Event Description

It was reported that the patient's caregiver noticed an internal infection about two weeks prior at the neck incision site. The patient had implant surgery on (b)(6) 2014. The infection was reported to have developed to be external with scabbing on the left side of the incision. The infection was not mentioned or visible at post-operative follow-up, as the company clinical specialist was present during most of the patient¿s appointments. No interventions for the infection have been reported to date.

 
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 Key4385251
Report Number1644487-2015-03527
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2018
Device MODEL Number304-20
Device LOT Number203034
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/14/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/17/2014
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: 01/06/2015 Patient Sequence Number: 1
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