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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 11/08/2010
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2010 were received on may 6, 2012 regarding this vns patient. The clinic notes allege that the patient's recent seizures have been different than those in the past. The patient reports doing things or having conversations after his seizures and then having no recollection of those events. Sometimes, he will wake up or become aware of his surroundings without knowing how he got there. The patient reports having pre-seizure activity one to two times per week. Occasionally, swiping his magnet will stop the seizure. The patient's last generalized tonic-clonic seizure was about one month ago ((b)(6) 2010). The patient's seizures are characterized as generalize tonic, clonic movements, deviation of eyes and head to one side and focal movements followed by generalized clonic movements. The seizures are preceded by an aura and followed by confusion and lethargy. The patient is having more difficulty remembering how he got to places, losing track of time, and his caretaker reports he just seems "out of it at times. " the patient has been incontinent at times but no tongue biting has been reported. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Review of programming/device diagnostic history performed.

 
Event Description

On (b)(6), 2012, a fax was received from the physician with information regarding the patient's change in seizure pattern from (b)(6), 2010. The physician stated that there was no relationship of the event to vns. The change in seizure pattern was not significant. The interventions taken included checking the patient's levels, educating the patient, and checking the vns. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the change in seizure pattern.

 
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Brand NamePULSE GEN MODEL 102R
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2595567
Report Number1644487-2012-01392
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number102R
Device LOT Number201104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/05/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/29/2009
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: 06/01/2012 Patient Sequence Number: 1
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