• 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 11/14/2013
Event Type  Injury  
Event Description

It was reported that the vns patient developed an infection and subsequently underwent surgery to explant the device. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. The patient has not been re-implanted to date.

 
Event Description

Additional information was received regarding the infection. In the month of (b)(6) 2014, a follow up appointment showed a dehiscent wound and infectious secretions. The culture showed e. Coli. Patient was admitted (b)(6) 2014. Patient's generator was explanted on (b)(6) 2014 and patient was discharged on (b)(6) 2014. Patient was readmitted (b)(6) 2014 due to secretions from the wound and extrusion of the electrode from the chest site, for which he was hospitalized and explanted partially on (b)(6) 2014. Culture showed staphylococcus aureus. He was kept in the hospital to receive antibiotic therapy. The explanted generator was returned on (b)(4) 2015. Analysis is underway but has not been completed.

 
Manufacturer Narrative

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

 
Event Description

Analysis of the generator showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4347863
Report Number1644487-2014-03423
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2015
Device MODEL Number103
Device LOT Number3750
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/11/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/17/2013
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: 12/19/2014 Patient Sequence Number: 1
-
-