• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • 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 300 Back to Search Results
Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction  
Event Description

During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.

Manufacturer Narrative

Device failure occurred, 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 300
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3414511
Report Number1644487-2013-03232
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/17/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2004
Device MODEL Number300-20
Device LOT Number5316
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/17/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial