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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 05/22/2010
Event Type  Death  
Event Description

It was reported that the cause of death was due to a subclavian clot and that the patient experienced a swallowing disorder and seizures. The hospital medical records indicated that the patient was hospitalized prior to the patient's death from (b)(6) 2010 and was diagnosed with dvts in the upper arms, respiratory distress, seizure disorder, dyspnea, altered mental status, gastro-esophageal reflux disorder and paranoid schizophrenia. It was reported that the patient was in hospice care at the time of his death, but that there are no records in the medical records office from that time. It was reported that the patient was buried and was most probably buried with the vns still implanted. It was reported that the vns helped the patient's seizures. Additional hospital notes were received from the hospitalization prior to death indicating that the patient was observed to have stopped breathing and was pronounced death on (b)(6) 2010. It was noted that the overall clinical impression was that the patient had respiratory failure and lactic acidosis secondary to recurrent aspiration pneumonia. The death certificate listed seizure disorder as the cause of death due to (or as a consequence of) swallowing disorder with aspiration, due to (or as a consequence of) subclavian vein thrombosis. The manner of death was listed as natural. No autopsy was performed.

 
Event Description

It was reported that the treating vns physician's office had not seen the patient since 2010 and had not future appointment. Upon review of the internet, the patient's obituary was found which reported the patient passed on (b)(6) 2010. Review of the company programming history database shows that the treating physician programmed the patient's device on (b)(6) 2010 and increased the output current at that time. Attempts for additional information from the physician have been unsuccessful to date. Follow-up with the funeral home revealed that it is not believed that the vns devices were explanted prior to burial.

 
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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 Key3232880
Report Number1644487-2013-02167
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2007
Device MODEL Number102
Device LOT Number012303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2005
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: 07/18/2013 Patient Sequence Number: 1
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