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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 04/27/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2102, clinic notes were received regarding this vns patient. All notes stated that the physician's diagnosis was that patient had increasing severe convulsive seizures not otherwise specified not greater than or equal to her non-epileptic seizures. Notes dated (b)(6) 2012 indicated that the patient's condition was worse. The patient had five seizures in the past two days, and the timing was different than before. The patient has a seizure on the school bus that lasted 5 minutes, the patient had on seizure when she got off of the bus that lasted 6 minutes. The patient's mother indicated that the patient had been seeing starting spells more in the last few weeks. The patient was disoriented, had trouble with speech, and slept through the night. The patient settings were provided. Notes dated (b)(6) 2012 indicated that the patient was having two seizures per month. The patient's condition was the same. Notes dated (b)(6) 2012 indicated that the patient had a seizure on (b)(6) 2012 when she was excited but was not swiped with the magnet. On (b)(6) 2012, the patient had another seizure on (b)(6) 2102 and was not swiped due to the sureness of the episode. On (b)(6) 2012, the patient had a seizure around 5 pm that lasted for 30 minutes. The patient was swiped 3 to 4 times and diastat was administered. The patient was disoriented, had trouble with speech, and slept through the night. The patient settings were provided. Attempts for additional information will be made.

 
Manufacturer Narrative

 
Event Description

A fax received on (b)(6) 2012 from the physician indicated that the increase in seizures was not related to vns. The patient's medication was increased, but the patient continued to have seizures. The increase in seizure frequency was to the patient's pre-vns baseline. The patient had convulsion nos seizures. External factors and medication needing changes preceded the increase in seizures.

 
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Brand NamePULSE GEN MODEL 102
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 Key2797829
Report Number1644487-2012-02680
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number102
Device LOT Number201139
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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