• 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
Device Problem High impedance
Event Date 06/26/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks were found in the parts of the lead that could be assessed; however, there was a suspect area in the lead portion near the tie-downs. Due to the quality of the images received, the lead wire could not be completely assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received stating that the x-ray images were reported by the physician to be unremarkable. The patient¿s device was tested again during an office visit on (b)(6) 2014 and system diagnostic results again showed high impedance. The patient¿s device was subsequently disabled. The patient was not able to pinpoint any previous events that may have caused or contributed to the high impedance.

 
Manufacturer Narrative

Explant date. If explanted, give date (mo/day/yr), corrected data: this information was inadvertently not included in manufacturer's supplemental report #2.

 
Event Description

Analysis showed that the quadfilar coil of one returned portion appeared to be broken approximately 12mm from the end of the cut inner silicone tubing. The fracture surface exhibited extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Setscrew marks observed near the end of the connection pin indicate that the lead had not been fully inserted into the header cavity of the generator at one time. The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except those described. No anomalies were noted with the returned pulse generator.

 
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
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 Key3957908
Report Number1644487-2014-01870
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number302-20
Device LOT Number2895
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/21/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-