• 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 09/11/2012
Event Type  Malfunction  
Event Description

The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

Manufacturer Narrative

Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Event Description

It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2784912
Report Number1644487-2012-02604
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device EXPIRATION Date06/30/2010
Device MODEL Number302-20
Device LOT Number200551
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/15/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/12/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial