• 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 10/16/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7). The patient device was not disabled as the patient did not complaint of any discomfort. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

It was also reported that the patient is anxious about not having vns as it has helped her in the past.

 
Event Description

The patient underwent a full replacement on (b)(6) 2016 due to battery depletion, unable to interrogate due to battery depletion and lead discontinuity. The generator and lead were received for analysis on 06/13/2016. Product analysis for the generator was completed and approved on 06/22/2016. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at a low battery condition (depleted). Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. With the exception of the parameters that are associated with a low battery condition, the device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.

 
Event Description

Product analysis on the lead was completed and approved on 07/01/2016. A small portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During product analysis abraded openings were found on the inner tubing. Abrasions were observed in various locations, possibly caused by wear. Connector pin and connector ring coil breaks were observed with abraded openings on the inner tubes. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break (found at 356mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on three of the broken coil strands. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. No other obvious anomalies were noted.

 
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 Key4251020
Report Number1644487-2014-03028
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 10/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2009
Device MODEL Number302-20
Device LOT Number1651
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/11/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-