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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 12/16/2014
Event Type  Malfunction  
Event Description

It was reported that, during initial implant surgery, the surgeon had difficulty inserting the lead pin into the generator header. The surgeon stated that the end of the lead was flimsy and felt as if there was air behind the lead pin that created a vacuum which would not allow pin insertion. The surgeon was able to insert the lead by twisting it into the generator header. No further information relevant to this event has been received to date.

 
Event Description

Analysis of the returned generator reported in manufacturer report #1644487-2015-03658 did not observe any obstructions in the header lead cavity or the connector blocks. In addition, the in-line cavity go gauge test passed and a bench in-line lead was able to be fully inserted into the pulse generator header.

 
Event Description

Additional information was received stating that the vns patient¿s device was tested and showed normal device function. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The patient underwent generator replacement surgery on (b)(6) 2015 due to painful stimulation. The lead was not replaced during the procedure. The painful stimulation event will be captured in manufacturer report #1644487-2015-03658.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

 
Event Description

Investigation into insertion difficulties during vns implant surgeries identified two potential causes of the issue. One possible cause is that deionized water was allowed to be used for lubrication during the assembly process of the lead. Another possible cause is the large o-ring boot diameter, which has direct impact on the maximum insertion force. The larger the o-ring boot diameter, the more insertion force is necessary to insert the pin into the generator. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key4412968
Report Number1644487-2015-03603
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device MODEL Number304-20
Device LOT Number203056
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/23/2014
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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