• 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

  • 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 Back to Search Results
Model Number 302-20
Event Date 12/04/2014
Event Type  Malfunction  
Event Description

The generator was returned for analysis on 1/12/2015. Product analysis was completed on 2/9/2015. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 949 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. Here were no performance or any other type of adverse conditions found with the pulse generator. The decoder spreadsheet shows that there was high impedance greater than 10,000 ohms seen prior to explant on (b)(6) 2014.

 
Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance and painful stimulation. Follow-up revealed that the patient began experiencing the painful stimulation on (b)(6) 2014. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. Patient manipulation or trauma is not believed to have caused or contributed to the event. It was noted that the patient¿s device battery was depleted and that surgery was scheduled to preclude a serious injury and to continue seizure treatment. The explanted devices have not been returned to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4392277
Report Number1644487-2015-03541
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/09/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2014
Device MODEL Number302-20
Device LOT Number2740
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2010
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: 01/07/2015 Patient Sequence Number: 1
-
-