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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 08/14/2012
Event Type  Death  
Event Description

Reporter indicated a vns patient had died due to confirmed sudep on (b)(6) 2012. The death was not related to the vns per the reporter. The vns lead and generator were explanted and have been returned for analysis. Attempts for further information are in progress.

 
Event Description

Reporter indicated that the patient was receiving vns therapy at the time of death. The patient was found in a cyanotic state in bed by caregivers, and resuscitation was unsuccessful. The death was not witnessed. The patient had a history of nocturnal seizures but no febrile seizures, no drug abuse history, and no history of cardiac or respiratory problems. The patient was compliant with seizure medications, and the last known blood drug levels were normal. The death was not felt to be related to the vns and was felt to possibly be due to sudep. Analysis was completed on the returned generator and lead. No anomalies were noted with the generator, and the generator performed per specifications. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since a large portion of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

Report source, corrected data: the initial mdr report inadvertently omitted the 'foreign' designation.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2745827
Report Number1644487-2012-02336
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number013118
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2005
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: 09/14/2012 Patient Sequence Number: 1
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