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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 06/03/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that this patient was referred for end of service generator revision and prophylactic lead revision. The patient¿s seizures were stronger. Clinic notes dated (b)(6) 2013 indicated that the patent¿s last seizures was on (b)(6) 2013. The patient has complex partial seizures with typical post-ictal duration of 2 minutes. The vns was noted to be not working, and the patient was referred due to worsening seizures. Notes dated (b)(6) 2013 indicated exacerbation of seizures, and phenytoin was added. The notes did not indicate that the generator was interrogated or adjusted at this appointment. Notes dated (b)(6) 2013 indicated no worsening of seizures with a post-ictal duration of 3 minutes. Follow-up showed that the patient was implanted with vns and now had more frequent seizures. On (b)(6) 2013, they checked the vns, and it was completely dead. The same programming system was used successfully with other patient¿s. The patient was using 3 heavy duty medications, and it was not controlling her seizures. After she was implanted with the vns the seizures got better. When the battery died she started having generalized seizures that she didn't have before. The physician attributed the increase seizures to the battery being at end of service. The patient was referred for revision. Surgery is likely but has not taken place.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3358054
Report Number1644487-2013-02805
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number104
Device LOT Number2597
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/16/2010
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: 09/19/2013 Patient Sequence Number: 1
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