• 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 102

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

CYBERONICS, INC. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 07/28/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Reporter indicated a vns therapy pt "decided to remove the battery himself. He literally removed the battery including the leads", and the incision became infected. The physician did not know the pt removed the vns therapy system. The pt's family reports the pt "has been doing strange things", since his medications were changed. Mfr records confirmed device sterility prior to shipment. The explanted vns therapy system has been returned to the mfr and is pending analysis. Good faith attempts to obtain add'l info have been unsuccessful to date.

 
Manufacturer Narrative

Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1528647
MDR Report Key1463630
Event Key1349302
Report Number1644487-2009-01858
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number200961
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/21/2009
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/30/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

-
-