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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 304 GENERATOR Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2017
Event Type  Injury  
Event Description

The patient's neck incision had dehisced and become infected. The patient was referred to neurosurgery. No known surgical interventions have occurred to date. The design history record was reviewed for sterility. It was noted that the lead was sterilized prior to being distributed. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined to not be related to vns therapy stimulation.

 
Event Description

Further information was received that the patient's lead and generator were explanted due to the infection. The infection had been reportedly treated by antibiotics up until the explant. Operative notes from the surgeon were also received and stated there was exposed lead at the neck region. The surgeon later confirmed that this was related to the same incision that had dehisced. Device evaluation is not necessary because the reported events have been determined to not be related to vns therapy stimulation. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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 Key6461018
Report Number1644487-2017-03563
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203828
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/15/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/06/2016
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: 04/05/2017 Patient Sequence Number: 1
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