• 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 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, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 04/24/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient's device was disabled on (b)(6) 2014. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. Due to the poor quality of the images, lead pin insertion and the filter feed-through wires cannot be assessed. 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 or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc - 7). The patient¿s device was not programmed off following the high impedance observation. Ct scans were provided to the manufacturer for review but were unable to determine the integrity of the lead and whether the lead pin was fully inserted into the generator header. The last known good system diagnostic results were from the date of implant. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. Further follow-up revealed that the implant surgeon hit the patient¿s jugular as he tunneled from chest to neck. The patient was seen 15 days after implant surgery and presented with severe voice hoarseness. The patient¿s device was programmed on during an office visit on (b)(6) 2013. During the office visit on (b)(6) 2014, the patient¿s device settings were increased. A diagnostic test was subsequently performed and a warning message appeared indicating high impedance and limited output current. The neurologist misinterpreted the diagnostic results and increased the patient¿s device settings. A second diagnostic test was performed which revealed the high lead impedance. It was reported that the patient was doing well. No known interventions have occurred to date.

 
Manufacturer Narrative

Manufacturer reviewed ct scans of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Ct scans reviewed by manufacturer, unable to assess lead continuity or lead pin insertion. 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 304
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 Key3823884
Report Number1644487-2014-01322
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2017
Device MODEL Number304-20
Device LOT Number202521
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/22/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/31/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-