• 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 08/27/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results showed high impedance (impedance value ¿ 5571 ohms). The neurologist stated that the high impedance observation may be indicative of an issue with the lead or fibrosis. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on 10/30/2014. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on the date of replacement surgery, where the impedance value changed from a normal limits range to high lead impedance. Analysis of the lead is currently underway.

 
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. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on the date of explant, where the impedance value changed from a normal limits range to high lead impedance. Prior to this change, lead impedance was within normal limits. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in both the electrode and body regions. Abraded openings of both outer and inner tubing were observed near the break area. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Event Description

Pitting was observed on the coil surface.

 
Manufacturer Narrative

Describe event or problem: corrected data: the previously submitted mdr inadvertently did not include information regarding the pitting that was observed during analysis of the lead.

 
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 Key4115707
Report Number1644487-2014-02460
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 08/28/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number302-20
Device LOT Number1273
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/30/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-