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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 12/17/2014
Event Type  Injury  
Event Description

It was reported that the vns patient developed an infection and would undergo device explant. It was reported that the infection was a post-operative infection and pus was seen at the generator site and superficially at the neck incision. The generator and majority of the lead were explanted on (b)(6) 2015. The surgeon plans to re-implant the device in 4-6 months.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

(b)(4). Additional manufacturer narrative; corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.

 
Event Description

Additional information was received that patient underwent lead and generator re implant on (b)(6) 2016. The implantation was on the right vagus nerve. Lead impedance of the new vns system was normal.

 
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Brand NamePULSE GEN MODEL 106
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 Key4532835
Report Number1644487-2015-03933
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2016
Device MODEL Number106
Device LOT Number4085
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/08/2014
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: 02/20/2015 Patient Sequence Number: 1
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