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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 05/06/2014
Event Type  Death  
Event Description

Additional information was received stating that the vns patient passed away from pulmonary hemorrhage probably from pulmonary embolism. The patient¿s parent stated that the patient did not look ok following implant surgery; however, the patient was cleared by the surgeon and anesthesiologist. The patient¿s device was never programmed on. An internal evaluation of the available information determined that the death was unlikely sudep.

 
Event Description

It was reported that the patient passed away the day following initial vns implant. The patient's mother reported that an autopsy was planned and that she did not know if the death was a complication of surgery, stroke, embolism, heart attack, etc. The surgeon indicated that he was "not able" to provide system diagnostics from the implant procedure to confirm device function at the time of implant. The patient was not receiving vns therapy at the time of death. Neither generator or lead were explanted after the patient's death. The believed cause of death was reported to be sudep. The surgeon indicated that the relationship between the vns and death was unknown. The surgeon indicated that an autopsy was not performed and that the patient was found unresponsive by the family. The patient had no history of drug or alcohol abuse and no history of cardiac or respiratory problems. The patient was compliant with antiepileptic medications.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the generator and lead confirmed all quality tests were passed prior to distribution.

 
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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 Key3853786
Report Number1644487-2014-01423
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 05/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device MODEL Number102
Device LOT Number202803
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2014
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: 06/06/2014 Patient Sequence Number: 1
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