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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 09/09/2014
Event Type  Injury  
Event Description

It was reported that the patient has been referred for surgery. The physician does not believe the events are related to vns therapy. No surgical interventions have been performed to date.

 
Event Description

Clinic notes were received stating that the patient was hospitalized due to reaction to the vns device. The patient¿s symptoms were reported to have been stable.

 
Event Description

On (b)(6) 2015, it was reported that the patient was scheduled for explant surgery as part of the incision site had opened and some of the generator is visible and exposed. The patient underwent removal of the vns on (b)(6) 2015. The explanted generator has not been returned for product analysis to date.

 
Event Description

It was reported that the recently implanted vns patient was hospitalized on (b)(6) 2014. The patient was experiencing coughing, breathing issues, nausea, vomiting, and chest pain at the generator site. Patient also stopped eating and had lost weight. The patient¿s caregiver wanted the patient¿s device explanted as the events began when the device was programmed on a week after vns surgery. The patient¿s seizures had increased and patient was on more seizure medications than prior to vns therapy. However, the surgeon and neurologist stated that the patient is fine. The patient is diabetic and was admitted with a very high blood sugar level. The patient¿s physician believed the events were due to the patient¿s high blood sugar levels as well as vns stimulation. Following revealed that the patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

It was reported that the hospital discards explanted devices and therefore the explanted generator cannot be returned for product analysis.

 
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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 Key4194303
Report Number1644487-2014-02789
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/22/2014 Patient Sequence Number: 1
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