• 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 01/01/2014
Event Type  Injury  
Event Description

It was initially reported that the patient had their generator and lead explanted due to neck pain. The explanted generator and lead were returned to the manufacturer for evaluation. Product analysis is planed but has not been completed. There was no replacement of the explanted products on the date of explant.

 
Event Description

It was clarified that the surgeon explanted the patient because the patient wanted to have a mri performed. The surgeon explained to the patient about having the vns removed, but the patient insisted on having the vns explanted. The patient was being treated for back and neck pain, and another physician told the patient that she needed a mri. The explant was done for the mri and not due to the pain. Analysis of the explanted devices was completed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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 Key4220713
Report Number1644487-2014-02902
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2007
Device MODEL Number102
Device LOT Number013894
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/13/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2005
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: 11/03/2014 Patient Sequence Number: 1
-
-