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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 07/01/2014
Event Type  Injury  
Event Description

It was reported on (b)(6), 2014 that the patient thinks the vns device may be depleted because his seizures have increased. The patient said he had four seizures the day before and 3 seizures today. The patient was referred for generator replacement. Although surgery is likely, it has not occurred to date. Although a blc was performed which showed 3. 64 years remaining until eri=yes; for model 100, 101, 102, and 102r pulse generators, frequencies of 5 hz or below for long-term stimulation generate an electromagnetic trigger signal, which results in excessive battery depletion of the implanted pulse generator. Per review of the patient¿s programming history, this generator was programmed to 1hz on two dates; therefore, the generator likely has reached or is nearing eos.

 
Event Description

On (b)(6) 2014 it was reported that the patient underwent generator replacement on (b)(6) 2014. It was reported that the explanted generator was discarded by the hospital and therefore cannot be returned for product analysis. Good faith attempts for further information from the physician have been made but have been unsuccessful.

 
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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 Key4008184
Report Number1644487-2014-01998
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/23/2007
Device MODEL Number102
Device LOT Number013755
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/19/2005
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: 08/14/2014 Patient Sequence Number: 1
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