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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 08/24/2013
Event Type  Injury  
Event Description

It was reported that the patient experienced a longer than usual seizure. The patient reported that she experienced a seizure today that lasted approximately a minute and a half and that swiping the magnet did not stop the seizure. The patient reported that since the vns was programmed on her seizures were reduced to 10-20 seconds at most until this seizure. No additional information has been received to date.

 
Manufacturer Narrative

 
Event Description

Further follow-up revealed that the patient was first seen by the physician on (b)(6) /2013. The patient reported a history of experiencing seizures twice a month. It was reported that a new grand mal type seizure was reported. The grand mal was occuring every week or so. The physician chose to increase the patient's zonisamide dosage. After this visit, the patient called the office on (b)(6) 2013 to report another grand mal. The physician increased the zonisamide again, and at the next visit on (b)(6) 2013 the patient reported seizure activity was back to her normal twice a month. There was no report of any grand mal type seizures. On the (b)(6) 2014, a new medication type was introduced and the seizure control was reported as improving. The patient was last seen on (b)(6) 2014. At this visit no adjustments were made to the vns device, and the settings remained at 1. 0/25/200/14/1. 8.

 
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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 Key3360682
Report Number1644487-2013-02836
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/24/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number105
Device LOT Number3439
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/26/2012
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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