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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104

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CYBERONICS, INC. PULSE GEN MODEL 104 Back to Search Results
Model Number 104
Event Date 09/11/2012
Event Type  Injury  
Event Description

Product analysis was completed on the returned generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The battery is partially depleted, 2. 649 volts (at ifi) as measured during completion of test parameter (measured diagvbat) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 107. 769% of the battery had been consumed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

The patient had a prophylactic replacement of their generator and it has been returned and analysis is pending completion.

 
Event Description

Clinic notes were received for review reporting that a vns patient was hospitalized for a seizure. Reported that the patient was an (b)(6) male who presented to the emergency department after a day of seizures that are "different than normal". His mother reported via the received notes at her childs last tonic clonic seizure was (b)(6) 2012 am around 6:30 and lasted 10-15 seconds. Later that morning he was having multiple episodes of "humming like casper" and "gazing into space" which were often accompanied by him losing tone in the upper half of his body and bending over. The patient the same day went to take a shower and was found in the tub head down. The patient's mother reported that they do not regularly use the' patient's vns, don't have the magnet around (reportedly at patient's school). The patient's mother also does not like giving her child diastat because it knocks him out and it "takes him 2-3 days" to recover from a dose. The patient had one recent drug change, his psychiatrist switched his risperidone from 0,5 mg bid, to 1 mg qhs. No recent stressors noted. No missed medications, no sick contacts. The patient had been sick two weeks earlier with vomiting and diarrhea. No treatment was sought for that. He additionally had an elevated blood pressure for him of 147/88 possibly related to their fall. They will keep monitoring for head injury signs and symptoms. The patient does have frequent absence-like seizures. Thus far no further information has been attained.

 
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Brand NamePULSE GEN MODEL 104
Type of DevicePULSE GEN MODEL 104
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 Key2772437
Report Number1644487-2012-02510
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number104
Device LOT Number201130
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/12/2012
Event Location Other
Date Manufacturer Received11/29/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2009
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: 10/04/2012 Patient Sequence Number: 1
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