• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

  • 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 - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem High impedance
Event Date 03/25/2019
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Patient presented with high lead impedance and the device was disabled. It was noted that the physician reviewed x-rays and was unable to determine whether or not a clear wire break was present. It was noted that the patient reported no longer feeling stimulation resulting in the impedance being checked and found to be high. X-rays were received and reviewed for the patient. The connector pin can be seen coming through the second connector. The filter feedthru were confirmed to be intact. The lead wires appeared intact at the connector pins. No gross discontinuities were identified in the visible portion of the lead. A sharp angle was noted at the top of what appears to be the strain relief loop. It should be noted that the sharp angle may be a result of the angle of the image. The cause of the patient¿s high impedance could not be determined based on the images provided. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Further information was received that the patient reported no trauma or manipulation to the area. It was noted that suddenly the stimulation was no longer perceived. No further physician¿s assessment of the high impedance was provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8624293
Report Number1644487-2019-00967
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number204222
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-