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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient had been experiencing whole body shakes since undergoing vns generator replacement surgery. The caregiver suspected these events were seizures which would be a new seizure type for the patient. It was reported that these body shake events do not occur with stimulation. The patient was seen by the physician after the caregiver reported the body shake events to the manufacturer. However the caregiver did not report these events to the physician and the physician was unaware of the body shake events. Therefore, the physician could not determine if these events were seizures and he could not assess their relationship to vns therapy. It was noted during the visit with the physician that diagnostics were ok and that the generator's settings are still being titrated up since implant. Manufacturing records for the generator was reviewed and found that it passed quality control inspection. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6002867
Report Number1644487-2016-02271
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 09/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/15/2018
Device MODEL Number106
Device LOT Number203703
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/17/2016
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: 10/06/2016 Patient Sequence Number: 1
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