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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 04/01/2012
Event Type  Injury  
Event Description

It was observed in the patient¿s clinic notes dated (b)(6) 2013 that the patient was experiencing a new and unusual seizure type and was referred for a generator replacement. The unusual seizure was followed by left sided weakness that last 1-2 hours with full recovery (most likely todd's paralysis). Work up including head ct, echo and "carotid us" were unremarkable. System diagnostics were performed and the device was not at end of service. However, it is believed that a warning message was observed during interrogation to replace the device as soon as possible. The patient's medication was increased, and no vns programming changes were made. Good faith attempts were made to the physician and it was later reported by the physician that the patient was experiencing an increase in seizures, not new and unusual seizure types. The patient¿s seizures improved since vns implantation initially then her seizures worsened. The physician stated that the patient was experiencing left side weakness in their body with a longer recovery time needed after the seizures took place. This event was first observed (b)(6) 2012. He is unsure at this time if the increase in seizure frequency is due to todd's paralysis or vns therapy. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure type. The patient has been referred for a generator replacement, due to the message noted on the handheld during interrogation stating that the device should be replaced as soon as possible. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2013, the patient underwent generator revision. The explanted generator was destroyed per hospital protocol.

 
Manufacturer Narrative

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3250578
Report Number1644487-2013-02259
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2008
Device MODEL Number102
Device LOT Number016639
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/19/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/25/2007
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: 07/26/2013 Patient Sequence Number: 1
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