• 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 105 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 105 GENERATOR Back to Search Results
Model Number 105
Event Date 03/11/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient went to the emergency room on (b)(6) 2014 due to a seizure. The patient had a fever and was admitted to the hospital that day for a possible infection at her incision site. The patient was discharged on (b)(6) 2014. The patient¿s device was tested at the hospital and reported to be functionally normally. The neurologist stated that the patient¿s seizure was due to her device being programmed to a low output current (0. 25ma). The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to infection. Wound cultures from the patient¿s lead incision site were taken but the results have not been provided. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

It was reported that the patient was re-implanted with vns on (b)(6) 2015. Due to infection surrounding the left vagal nerve previously, the surgeon elected to implant on the right vagus nerve based on his medical judgment.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the incorrect age. Date of event, corrected data: the initial report inadvertently reported the incorrect date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key3812438
Report Number1644487-2014-01272
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number105
Device LOT Number3790
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/13/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/15/2014 Patient Sequence Number: 1
-
-