• 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 PULSE GEN MODEL 103; GENERATOR

  • 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 PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problem High impedance (1291)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 12/05/2014
Event Type  Injury  
Event Description
It was reported that the vns patient was experiencing pain in her neck and chest during stimulation on-times and was constantly sore at areas around the lead.The patient¿s lead was found to be visible in the patient¿s neck where it previously was not visible.The patient¿s device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 3062 ohms).Patient trauma is not believed to have caused or contributed to the high impedance.The physician believed that the issues were related to an end of service condition with the patient¿s device.A battery life calculation using the available programming history showed approximately 7.4 years until near end of service.The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 103
Type of Device
GENERATOR
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 Key4397157
MDR Text Key5365327
Report Number1644487-2015-03563
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/30/2011
Device Model Number103
Device Lot Number2612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/10/2014
Initial Date FDA Received01/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR
-
-