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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient was scheduled to undergo a replacement surgery. During the replacement surgery the surgeon found that the patient¿s generator had migrated further than the neurosurgeon had anticipated and so he explanted the patient¿s vns in order to allow the pocket to heal. Cultures were taken at the time of the patient¿s surgery to determine if an infection was present. Follow up with the surgeon¿s office indicated that the cultures confirmed infection and that there was skin dehiscence, wound breakdown, and pus observed when the physician opened the patient. The surgeon also noted that the was a bit of trauma that had occurred to the patient¿s skin recently. The patient was discharged after surgery but then came back to the hospital later that day because she was not feeling well. Ten (10) minutes after returning to the hospital the patient went into cardiac arrest where she was placed on life support. The patient¿s organs then began shutting down and the patient passed away. The neurologist ¿s notes were reviewed and there was no mention of attributing the death to vns therapy. The patient's explanted generator has been received and is undergoing product analysis. The surgeon also indicated that he did not use a non absorbable suture to anchor the patient's generator in the subcutaneous pocket. A design history record review found that the patient's generator was sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

 
Event Description

The patient was admitted to the hospital on (b)(6) 2017 due to increased seizures frequency and feeding intolerance. The patient had her medications were increased before the decision was made to induce coma. The patient was trialed on an anesthetic but developed a diffuse reaction, so she was then started on propofol infusion. On (b)(6) 2017 the patient developed severe acidosis and hypotension that resulted in cardiac arrest. The patient was then placed on life support where her kidneys began shutting down. The physician then attempted to improve the patient's electrolytes to help her heart cardiovert. However two attempts failed to cardiovert the patient. An electrophysiologist verified that the patent's heart would not likely recover. The patient's family then elected to remove the patient from life support. The explanted lead and generator were received for product analysis. Migration, wound dehiscence and infection are outside of the scope of product analysis. No anomalies were found with the generator that affected its functionality. Only a portion of the lead was returned and there was no noted discontinuity in the lead. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key6292580
Report Number1644487-2017-03107
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number103
Device LOT Number202360
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2013
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: 02/01/2017 Patient Sequence Number: 1
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