• 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 02/13/2015
Event Type  Malfunction  
Event Description

The patient underwent generator replacement surgery on (b)(6) 2015. It was reported that device diagnostics performed three times with the new generator and existing lead were within normal limits. The lead was not replaced. The patient was seen for follow-up with the surgeon at which time device diagnostics results in high impedance (>10,000). The patient was scheduled for lead replacement. The patient underwent lead replacement on (b)(6) 2015. There was no clear evidence of a lead fracture observed during explant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and diagnostic results revealed high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
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 Key4587780
Report Number1644487-2015-03723
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 02/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2012
Device MODEL Number302-20
Device LOT Number2266
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/13/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/19/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-