• 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 302 Back to Search Results
Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction  
Event Description

It was reported that high impedance warning message was received upon programming the patent¿s device. They device was tested again with the device programmed off, and diagnostics were reportedly fine. After the mri was completed and the patient was turned back on, system and normal mode diagnostics resulted in high impedance. An ap chest x-ray image was received for review. The generator appears normally placed on the left chest. The connector pin insertion into the connector block cannot be properly assessed. Some of the lead is not visible at the generator site, and appears to be partially behind the generator. Due to the limited x-rays taken and image quality, the electrodes and strain relief are unable to be assessed. Based on the image seen, the cause of the high impedance was unable to be determined. The lead continuity cannot be assessed and discontinuity on the lead or at the generator cannot be properly visualized. No assessment can be made on the portion of the lead that is not visible. The patient's device was programmed off due to the high impedance. The nurse reports that the patient has drop attacks and thinks the patient fell during a seizure most likely damaging the system. The patient has been experienced increased seizures recently. No known trauma or manipulation has occurred. The patient had generator and lead replacement surgery on (b)(6) 2015. The explanted products have not been received to date. Good faith attempts for additional relevant information have been unsuccessful to date.

Event Description

An analysis was performed on the returned lead portions and generator. During the visual analysis of the lead, quadfilar coil 1 appeared to be broken. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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 pin 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to reported events. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator internal data revealed that a >25% change in impedance occurred on 01/27/2015 from 2028 ohms to 9674 ohms (high impedance).

Event Description

Abraded openings were observed on the inner silicone tubes in one area of the lead, and the quadfilar coils appeared to be exposed and touching, in some areas.

Manufacturer Narrative

Manufacturer reviewed x-ray image of implanted device. X-ray image reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #2 inadvertently did not report this data.

Manufacturer Narrative

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

Event Description

The explanted generator and lead were received by the manufacturer for analysis. However, the analysis has not been completed to date.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
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 Key4565609
Report Number1644487-2015-04031
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Type of Report Initial,Followup,Followup,Followup
Report Date 02/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number302-20
Device LOT Number010489
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/05/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 03/03/2015 Patient Sequence Number: 1