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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 07/13/2014
Event Type  Injury  
Event Description

It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Clinic notes were received indicating that the vns patient was scheduled to undergo surgery on (b)(6) 2014 to explant her device. The patient had been hospitalized due to vomiting, diarrhea, sinus bradycardia, and voice hoarseness. The patient was given new medication and her device was disabled. It was noted that the patient¿s voice issues continued despite device disablement. The patient¿s device was tested and showed normal device function. The patient was seen by a cardiologist who determined that the patient had a history of nighttime bradycardia. The patient stated that she also had recently experienced bradycardia during the daytime. The patient had a history of chronic chest pain and was unable to tolerate stimulation at high settings due to the chest pain. The patient wanted her device explanted because it was uncomfortable and reportedly did not help with her seizures. Follow-up revealed that the patient¿s anxiety, nausea, voice alteration, vomiting and diarrhea were all related to vns stimulation. As the patient¿s device settings were increased, the patient¿s bradycardia had worsened and the patient was a non-responder to vns. The neurosurgeon stated that the patient did not have a prior history of cardiac events nor any pre-existing conditions susceptible to cardiac events. Additionally, the neurosurgeon indicated that the patient developed bradycardia following implant surgery. The patient underwent surgery on (b)(6) 2014 to explant her device. The explanted device has not been returned to date.

 
Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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Brand NamePULSE GEN MODEL 105
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 Key4013497
Report Number1644487-2014-02041
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number105
Device LOT Number202722
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/30/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2013
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: 08/15/2014 Patient Sequence Number: 1
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