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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 12/12/2011
Event Type  Injury  
Event Description

Additional information was received about the patient's vns explant surgery. It was reported that the patient had recently had a vns instillation that went very well, she actually had fewer seizures. Her seizures changed in character. With vns they were shorter and less severe and also the power of having the magnet to swipe and stop a seizure. Unfortunately, there was a (b)(6) infection and vns had to be removed. Three days prior to their removal of their vns generator and wound washout their mother noticed that her daughter was having trouble swallowing, and then during a coughing fit, broke open her neck incision and purulent discharge poured forth in a large volume. The patient was brought to clinic and was admitted to the hospital and scheduled for operative removal and washout of her wounds. Since explant the patient continues to have seizures the same as she had previously and her review is again consistent with extremely low functioning. The patient's mother is going to have a consult planned in the future for reimplant of their device.

 
Manufacturer Narrative

Suspected medical device operator of device corrected data; updated to patient. Corrected data: surgery was (b)(6) 2012. A 30 day report omitted of initial report.

 
Event Description

Additional information was received that the patient would go to surgery (b)(6) to have their generator reimplanted. Since their explant the patient has been having multiple daily seizures, she is very difficult to take care of and can be very aggressive. The infection was a (b)(6) and they were treated with antibiotics for approximately 2 weeks.

 
Event Description

It was reported that the patient's incision site looked raised, but was not red per physician. The patient had the vns device removed.

 
Event Description

Additional information was received that the patient may have their vns device reimplanted in the future. No surgery date is set at this time.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2414468
Report Number1644487-2012-00110
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number103
Device LOT Number201879
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date05/30/2012
Event Location Other
Date Manufacturer Received05/30/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2011
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: 01/13/2012 Patient Sequence Number: 1
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