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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/22/2010
Event Type  Injury  
Event Description

Reporter indicated a vns patient was having breakthrough seizures in (b)(6) 2010 and (b)(6) 2011, and that the patient had sleep apnea. Adjusting the vns settings seems to worsen the sleep apnea per the reporter. Vns diagnostics results from (b)(6) 2011 indicate the vns was performing as intended and was not at end of service. Attempts for further information are in progress.

 
Event Description

Reporter indicated the patient had vns generator replacement surgery due to end of service. The patient's seizures are attributed to disease process and not the vns, and the level of the seizure increase was about the same as pre-vns baseline levels. No events precipitated the increased seizures. The patient's sleep apnea is worsened by the vns stimulation. A polysomnogram showed that the patient has apnea when the vns stimulates, even when using c-pap treatment. The sleep apnea is pre-existing to the vns implant. The explanted generator was returned for analysis and found to be at normal end of service, and no anomalies were identified.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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 Key2258122
Report Number1644487-2011-02229
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/26/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/30/2004
Device MODEL Number102
Device LOT Number7195
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/23/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/16/2002
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: 09/21/2011 Patient Sequence Number: 1
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