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

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R 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 - HOUSTON PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem High impedance
Event Date 02/05/2018
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was stated by the neurologist office that the patient passed away. The office did not have any records as to the exact date or the circumstances of his death. Per death certificate, the cause of death was listed as cariopulmonary arrest, acute respiratory failure, and pneumonia. No additional relevant information has been received. High impedance was observed for patient's device prior to patient's death. This is reported in mfr. Report # 1644487-2018-01508.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7824973
Report Number1644487-2018-01511
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number102R
Device LOT Number2518
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/07/2009
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: 08/28/2018 Patient Sequence Number: 1
-
-