• 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

  • 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 Back to Search Results
Model Number 103
Event Date 01/01/2011
Event Type  Injury  
Event Description

It was reported via clinic notes received that the pt has obstructive sleep apnea, asthma, and a previous electrocardiogram indicated an arrhythmia. It was noted on the clinic notes that a recent electrocardiogram showed a "sinus arrhythmia"; however, it is not known if this is the same arrhythmia or a separate one. The relationship of these events to vns is not known. Diagnostics dated (b)(6) 2011 indicated normal device function. Attempts for additional info have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key2316734
Report Number1644487-2011-02590
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2631
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/27/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
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: 10/27/2011 Patient Sequence Number: 1
-
-