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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/18/2014
Event Type  Injury  
Event Description

It was reported that the patient was scheduled for vns debridement. The patient had recent generator and lead replacement surgery on (b)(6) 2014. The surgeon¿s office reported that the patient had a post-operative infection. As a result, the plan was to debride and drain the spot on skin. The patient had surgery on (b)(6) 2015 to debride, and the patient was subsequently referred to the infectious disease doctor.

 
Event Description

It was reported that the patient was scheduled for re-implant surgery. However, surgery has not occurred to date.

 
Event Description

An implant card was received which reported that the patient was re-implanted with a vns therapy system.

 
Manufacturer Narrative

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

 
Event Description

The reimplanted vns system was placed on the left vagus nerve.

 
Event Description

It was reported that the patient was scheduled for revision surgery. The surgeon planned to remove the vns system due to the infection, let it heal for a couple of weeks, and then go back in and either place the generator on right with electrodes on left vagus nerve or completely re-implant the system on the right side anatomy. It was reported that during surgery on (b)(6) 2015, the surgeon nicked the jugular vein when trying to cut the lead with less than 2 cm remaining. The bleeding was controlled with the use of a clip that was inserted. The pocket site culture that was completed was positive for an infection. The plan was to treat the patient with antibiotics. It was reported that the patient first presented with a staph infection on (b)(6) 2015 with a fluid-filled chest pocket. The nurse was unsure if the neck incision was also infected at that time. Antibiotic bactrim was prescribed but not successful as the patient was unable to tolerate. The patient was seen again on (b)(6) 2015 and was referred to infectious disease. The patient was seen on (b)(6) 2015, and keflex was prescribed at that time. After the patient was seen by the surgeon on (b)(6) 2015 again, the decision was made to explant.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key4476743
Report Number1644487-2015-03736
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number103
Device LOT Number4029
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/11/2014
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: 02/02/2015 Patient Sequence Number: 1
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