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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 Adverse Event Without Identified Device or Use Problem
Event Date 11/24/2007
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was found through an obituary search that the patient had passed away. A battery life calculation was reviewed and showed the device was working as intended as the dcdc value was within normal limits. No anomalies were observed. Additionally, the battery life calculation estimation showed approximately 9. 4 years were remaining at the time of the patient's death; therefore, the device was likely still functioning. It was later reported by the patient's last known physician that he saw the patient the spring prior to her death. He stated he believed the death was not related to vns; however, since he did not see her at the time of her death, he could not be certain. Additionally he noted the patient also had lung issues (unrelated to vns) and rhett's syndrome.

 
Event Description

A death certificate was later received showing the patient died of leukopenia, anemia, and thrombocytopenia. The death was noted to be natural.

 
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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 Key6438083
Report Number1644487-2017-03491
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2005
Device MODEL Number102
Device LOT Number8625
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/16/2003
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: 03/27/2017 Patient Sequence Number: 1
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