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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 03/10/2014
Event Type  Injury  
Event Description

It was reported that the patient's device has been programmed off after the patient was seen in the hospital for cyanosis. It was reported that the patient is hospitalized and undergoing a swallowing test. Further follow-up revealed that the device was programmed on and the patient was unable to tolerate device stimulation the device was programmed off. The physician plans to leave the vns programmed off for a few months before programming the device back on. It was reported that the patient was non-verbal and was not eating or drinking per the patient's mother. The mother reported that the patient seemed agitated. No medication changes occurred that is believed to have caused or contributed to the events. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

New information changes the address previously reported in initial mfr. Report.

 
Event Description

Additional information was received stating that the vns patient had approximately 80 ¿big¿ seizures in a week. The patient was taken to the er and was induced into a coma on (b)(6) 2014. It was reported that the patient¿s device was affecting her vocal cords and her ability to swallow. The patient experienced bad gagging episodes for three months and subsequently had her device disabled on (b)(6) 2014. The device has not been programmed back on to date. Further follow-up revealed that the reported event was not related to vns. The patient had a medical history of cyanosis prior to vns. The patient has since recovered. No other interventions have occurred to date. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the cyanosis and hospitalization. This event was also reported in manufacturer report # 1644487-2014-01178.

 
Manufacturer Narrative

Date of event; corrected data: additional information indicates that the event occurred on (b)(6) 2014.

 
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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 Key3752033
Report Number1644487-2014-01014
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number103
Device LOT Number202011
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2012
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: 04/15/2014 Patient Sequence Number: 1
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