• 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 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, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 01/01/2011
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2011 were received and during the review of the notes, it was observed that bradycardia was observed when the patient wore a holter monitor with a bpm of 39 and a tilt table test was positive with bradycardia per the family. The patient does have carotid stenosis and is taking statin and aspirin (81 mg) therapy. The carotid ultrasound in (b)(6) 2011 appeared stable with moderate right carotid plague but no significant stenosis. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2420530
Report Number1644487-2012-00154
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102R
Device LOT Number016065
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/22/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/20/2006
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: 01/18/2012 Patient Sequence Number: 1
-
-