• 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 01/13/2014
Event Type  Malfunction  
Event Description

It was reported that no x-rays were performed. Surgery is scheduled, but has not occurred to date.

 
Event Description

Product analysis was completed on the lead. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. The additional 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 portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the stated allegation of high impedance. 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.

 
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2014, it was reported that the patient was seen in clinic on (b)(6) 2014 and high impedance was observed on diagnostics. The cause of the high impedance was unknown by the physician. The vns generator was not disabled at the time; however, it was stated that it would be disabled when the patient was next seen. The patient was seen again on (b)(6) 2014. Per the report, the patient was last seen on (b)(6) 2014 at which time high impedance was first observed. X-rays were not yet ordered, as it was unknown if the surgeon would want them. There was no reported trauma or manipulation, and no change in seizures. Magnet mode was run in the office and it was found that the patient no longer feels magnet stimulation. No changes were recently made to the magnet settings or other settings. The physician decided to leave the vns device turned on as the patient is not experiencing any pain. Surgery is likely, but has not occurred to date.

 
Manufacturer Narrative

Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, 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 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 Key3627265
Report Number1644487-2014-00406
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number302-20
Device LOT Number200754
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/15/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-