• 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 102; 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 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 04/21/2014
Event Type  malfunction  
Event Description
It was reported in clinic notes that the patient had an increase in seizures.The patient had recently been released from prison and while they had good seizure control while incarcerated, they had some increased seizure activity upon release.The programming history was reviewed and no anomalies at the time of the event were seen.No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8331996
MDR Text Key135940205
Report Number1644487-2019-00268
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/17/2015
Device Model Number102
Device Lot Number202430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 01/18/2019
Initial Date FDA Received02/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age36 YR
-
-