• 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 LEAD MODEL 302-20

  • 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 LEAD MODEL 302-20 Back to Search Results
Model Number 302-20
Event Date 07/09/2011
Event Type  Malfunction  
Event Description

It was reported that the pt was rushed to emergency room this past weekend for increase in seizures. Emergency room says his lead wires are "tangled". Further info reveals that the pt underwent lead revision surgery due to a lead break and high impedance. The lead break was confirmed via chest x-ray per physician. Attempts for further info and product return have been unsuccessful to date.

 
Manufacturer Narrative

Device failure occurred.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302-20
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2227746
Report Number1644487-2011-01855
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2010
Device MODEL Number302-20
Device LOT Number200489
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/13/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2007
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: 08/12/2011 Patient Sequence Number: 1
-
-