• 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
Event Date 06/08/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, follow up with the admitting hospital's director of infection was performed. The director obtained information from the patient's charts and stated that the patient was admitted on (b)(6) 2012. The patient came in with pneumonia and erythema at both the neck and chest incision sites. The patient was given antibiotics and intravenous fluids. Blood cultures were taken with negative results. The patient was diagnosed with left neck surgical wound infection and sepsis. The patient returned on (b)(6) 2012. Dehiscence was seen; however, no interventions were taken as the incision appeared to be healing well. The relation of the pneumonia to vns was unknown.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6), 2012, this vns patient reported that she was implanted on (b)(6), 2012. The patient was implanted in (b)(6) and remained there for two days post operatively for an incision check, at which time she was well. One day after returning to (b)(6), the patient began to feel ill and was taken to the emergency room. The patient was admitted for pneumonia and incision infection. The patient stated that she spent two days in the hospital and received multiple antibiotics. When the patient reported this event on (b)(6), 2012, she stated that she was back at home, that she was feeling better, and that the incisions were looking better. On (b)(4), 2012, manufacturer records were reviewed. It was confirmed that both the generator and lead were sterilized prior to distribution. On (b)(6), 2012, follow up with the admitting hospital revealed that the patient had been admitted on (b)(6), 2012 and discharged on (b)(6), 2012. Attempts for additional information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2646272
Report Number1644487-2012-01714
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number103
Device LOT Number202053
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/10/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2012
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: 07/09/2012 Patient Sequence Number: 1
-
-