• 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
Device Problem Insufficient Information
Event Date 06/01/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient had been experiencing an increase in seizures for the past few weeks and may have developed a new seizure type. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Review of the patient's programming history available in the manufacturer's programming history database revealed diagnostics data for the date of implant, (b)(6) 2013.

 
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
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 Key4956763
Report Number1644487-2015-05383
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Followup
Report Date 07/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number103
Device LOT Number3771
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2013
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: 07/31/2015 Patient Sequence Number: 1
-
-