• 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 07/30/2014
Event Type  Malfunction  
Event Description

It was reported that during generator implant, the rubber septum plug over the set screw popped out when the surgeon was tightening the set screw. It was reported that the plug fell out of the sterile field. The plug was unable to be located within the or and a new generator was implanted. It was reported that the physician did not use any excessive force that may have caused the plug to come off. It was reported that the plug popped out easily as if it was not attached. The generator was returned for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

 
Event Description

Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.

 
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 Key4042354
Report Number1644487-2014-02115
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number105
Device LOT Number203011
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/02/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-