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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
Device Problem Insufficient Information
Event Date 04/09/2014
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported by the physician that the patient had deceased. An obituary was found which found the patient had passed away on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

It was reported by the funeral home the patient had a graveside burial. It was noted the patient probably did not have the vns device explanted as it was just a burial. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was found that in the state of (b)(6), vital records are not open to the general public and can only be obtained by the individual, guardian, or other legal party and the death certificate will not be able to be obtained from the state of missouri by the manufacturer.

 
Event Description

It was reported through hospital notes received by the manufacturer that the contributing factors to the patient's death were aspiration, refractory seizures, and history of renal cell cancer. The contributing factors for the patient's admission to the hospital were thrombocytopenia, seizure disorder, and hypernatremia. No additional relevant information has been received to date.

 
Manufacturer Narrative

Outcomes attributed to adverse event: death. Initial mdr inadvertently omitted outcome attributed to the adverse event and date of death. Type of reportable event: death. Initial mdr inadvertently marked the type of reportable event as serious injury instead of death.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5193626
Report Number1644487-2015-06287
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup
Report Date 10/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number102
Device LOT Number016274
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2006
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: 11/01/2015 Patient Sequence Number: 1
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