• 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 102 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 102 GENERATOR Back to Search Results
Model Number 102
Event Date 04/02/2014
Event Type  Malfunction  
Event Description

The physician reported that the programming system issue has resolved and no further issues have been observed. The physician reported that the patient does not have an appointment scheduled until (b)(6) 2014 and that the patient has not had any complaints or concerns.

 
Event Description

It was reported that the patient's device was unable to be interrogated. The physician performed troubleshooting and identified that an error message indicated "procedure failed, error in communication". The physician's office indicated that this is the first occurrence that this message had been received. The physician ensured that the programming system was not plugged into the wall and that all cables were secure; however, the issue still occurred. The physician requested that a company representative come troubleshoot the programming system. A company representative performed troubleshooting on the physician's handheld. It was reported that the handheld was not recognizing the new version software that was installed in the handheld. The company representative performed and hard reset and loaded the new software successfully. It was also determined that the wand battery was depleted, which was replaced. The handheld and wand successfully interrogated and performed diagnostics on demo generators. The patient has not been seen again since the troubleshooting on the programming system; therefore, it is unknown whether or not the patient's generator is now able to be communicated with.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
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 Key3787195
Report Number1644487-2014-01181
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number102
Device LOT Number2429
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/12/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-