• 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

  • 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 Back to Search Results
Model Number 102
Event Date 01/01/2010
Event Type  Injury  
Event Description

It was reported that the pt was to have her vns device removed for an unk reason. Follow-up with the treating physician reveals that the pt was experiencing a "shocking" sensation when she turned her head to the left. X-rays were taken and reviewed by the manufacturer. Upon review, no anomalies were noted with the device. Pt underwent surgery to replace the generator on (b) (6) 2010. Per treating physician, the surgery was prophylactic and there were no functional problems with the generator either before or after surgery. However, the surgeon felt the surgery was performed to preclude a serious injury as the pt was feeling "shocking" which could have caused injury. The surgeon felt the shocking was due to the generator nearing end of service. No trauma or manipulation occurred and no causal or contributory programming or medication changes preceded the onset of the shocking sensation. Per treating physician, the shocking sensation has resolved since surgery. Product has been returned to manufacturer, but analysis is pending.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1692487
Report Number1644487-2010-01176
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014188
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/23/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/16/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2005
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: 05/14/2010 Patient Sequence Number: 1
-
-