• 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 03/01/2013
Event Type  Injury  
Event Description

It was reported that the patient has an infection and will undergo generator explant. It was reported that the lead will be left in place. It was reported that reimplant is planned at a later time. It was reported that the patient has a chronic neck infection that appears to be associated with the vns. Several types of antibiotics were tried ; however, the neck incision reopened again. It was noted that a small amount of granulation tissue is in the medial aspect of the neck wound. The patient underwent generator explant on (b)(6) 2014. It was reported that the explanted device will not be returned for analysis. The physician reported that the infection started six months following implant. The patient became sick and was hospitalized. The physician reported that the infection started at the generator site and traveled to the neck through the tunneled site. It was reported that the neck wound grew (b)(6). Multiple antibiotics were administered and the neck site was ok. The physician reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the infection. No additional relevant information has been received to date.

 
Manufacturer Narrative

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

 
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
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 Key3815763
Report Number1644487-2014-01274
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/16/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number202105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/16/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/09/2012
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: 05/16/2014 Patient Sequence Number: 1
-
-