• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/14/2013
Event Type  Death  
Event Description

It was reported that the vns patient passed away. No additional information was provided at the time of initial report. An online obituary was found and noted that the patient passed away at the hospital. Further follow-up revealed that the patient was admitted to the hospital with a low hemoglobin and hematocrit and tachycardia; however, a cause of death was not yet known. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

It was reported that it was believed that the death certificate listed gastrointestinal disease/ulcer as the cause of death, but that the copy was too hard to read. It was reported that no autopsy had been performed and there was no knowledge of device explant. The patient was cremated. The hospital discharge summary indicated that the patient was admitted after being found severely anemic with dark bloody stools and more frequent seizures. It was noted that the patient had significant blood loss and had hemorrhagic shock requiring 6 units of packed red blood cells and vasopressor support. The patient underwent endoscopy with control of bleeding, but developed supraventricular tachycardia. The patient failed to return to his usual state of mental activity and his anti-epileptic therapy was adjusted. An eeg showed subclinical seizure activity. On the day prior to death, the patient developed persistent heart rates in the 170s to 180s that did not respond to cardizem, adenosine or amiodarone and he became more hypotensive. It was noted that the patient's family decided on comfort measures only, and the patient ultimately expired. It was noted that the vns was interrogated and was functioning appropriately. The esophagogastroduodenoscopy showed a large duodenal ulcer. Echocardiogram showed hyperdynamic left ventricular systolic function and eeg showed abnormal eeg consistent with both a generalized seizure disorder and possibly a focal area of dysfunction in the right temporo-parietal region. The final diagnoses was listed as acute upper gastro-intestinal bleed due to large duodenal ulcer, complex seizure disorder with subclinical seizure activity, acute blood loss anemia with hemorrhagic shock, supraventricular tachycardia, hypertension, hypothyroidism.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
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 Key3530505
Report Number1644487-2013-03864
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number103
Device LOT Number201269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/29/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2009
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: 12/20/2013 Patient Sequence Number: 1
-
-