Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

MAUDE Adverse Event Report

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

CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR   Back to Search Results
Model Number 102
Event Date 08/01/2005
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

Reporter indicated that the pt is going to have the vns system explanted due to psychosis actions. The pt has reportedly threatened to remove the device themself. The physician reported that the device is currently on. It was also reported that the patient was started to be weaned off of dillantin. It was further reported that the patient did not show for up their recent appointment with the surgeon for a surgery consult.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVNS THERAPY PULSE
Type of DevicePULSE GENERATOR
Baseline Brand NameVNS THERAPY PULSE
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number102
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed06/20/2002
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key628002
MDR Report Key638454
Event Key607148
Report Number1644487-2005-00631
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/30/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2005
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/31/2005
Device MODEL Number102
Device LOT Number9307
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/30/2005
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

 
-
-
-
-
-