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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/01/2008
Event Type  Injury  
Event Description

It was reported that the vns patient¿s device was disabled and later explanted on (b)(6) 2013 due to respiratory issues. The patient previously experienced trauma to the airway and was respiratory issues during stimulation on-times even at low settings. The patient¿s explanted device has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2009. The patient¿s device was disabled on (b)(6) 2010.

 
Manufacturer Narrative

 
Event Description

Further follow-up revealed that the patient's device was programmed off on (b)(6) 2010 and that after a year with vns disabled the patient decided to pursue explant in the future. The patient first complained of respiratory stridor and shortness of breath symptoms in (b)(6) 2008. The vns was programmed off and an ent evaluation was performed. The patient's respiratory symptoms were better with vns off. The vns was programmed back on in 2009 and the patient required albuterol, prednisone and continued to have problems with shortness of breath. There was questionable asthma of new onset which was always relieved with vns off. Many attempts were made to continue vns and manage with asthma medications, but they did not help the severe shortness of breath attacks. The physician believes the vns stimulation is related to the patient's respiratory issues. The patient underwent a video stroboscopy in 2009, a vocal cord ct scan in 2011, and a diagnostic laryngoscopy under anesthesia and laryngeal emg in 2011. The patient had emergency room visits and trials with vns stimulation off then on then off again. No programming changes, medication changes, or other external factors caused or contributed to the patient's respiratory issues. The physician reported that the patient experienced prolonged intubation for a period prior to vns implant and possible structural problem of post glottis inlet. The physician reported that the patient's depression benefitted from vns therapy so the respiratory problems were tried to manage for years.

 
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Brand NamePULSE GEN MODEL 102
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 Key4059317
Report Number1644487-2014-02201
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2010
Device MODEL Number102
Device LOT Number200742
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/20/2008
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: 09/04/2014 Patient Sequence Number: 1
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