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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 06/04/2012
Event Type  Death  
Event Description

This death event has been evaluated and with the available information the death has been determined to be possible sudep. Even though the funeral home reported the cause of death was cardiorespiratory failure, this is very vague and ultimately all deaths occur as a result of cardiorespiratory failure in some manner. The circumstances of the death, the general health of the patient, location of the death (inpatient or at home), and if seizures were involved with the death are all still unknown. As such, sudep cannot be ruled out as a possible cause of death.

 
Event Description

On (b)(6) 2012, the patient's death certificate was received. The certificate indicated that the patient passed in a natural manner. The underlying cause was cardiorespiratory failure (few days), septic shock with multi-system organ failure, and chronic liver disease with (b)(6). Follow-up with the patient's physician showed that no information was available regarding the patient. A sudep evaluation was performed with the new information. This death event has been reviewed and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was cardiorespiratory failure, septic shock with multi-organ failure, and chronic liver disease with (b)(6). Although the location of the death is not listed on the death certificate, it is likely the patient died in a hospital setting due to the reported event of septic shock and multi-organ failure. The patient was likely in a poor state of health at the time of death, and the death was likely witnessed.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

On (b)(6) 2012, a vns patient's son reported that the vns patient had recently passed away. The son reported that the death was not related to vns. An online obituary search showed that the patient's date of death was (b)(6) 2012. On (b)(6) 2012, follow up with the funeral home and physician's office was performed. Follow up with the associated funeral home revealed that the device was explanted prior to burial and discarded. It was also stated that the cause of death was cardio-respiratory failure. The physician's office stated that the patient had not been seen for some time. A battery life calculation was performed on (b)(6) 2012 with 9. 18 years to eri=yes. Attempts for additional information 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2672168
Report Number1644487-2012-01900
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2012
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 Number016672
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2007
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: 07/27/2012 Patient Sequence Number: 1
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