• 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 04/25/2011
Event Type  Injury  
Event Description

It was reported that a patient had an episode of intermittent esophageal pain that lasted several hours. The generator's normal mode output was disabled, although the magnet output was left programmed. The patient did complain of pain when using the magnet. Diagnostic testing on (b)(6) 2009 showed the device to be properly functioning. Furthermore, the patient's generator was reported to be able to move around in her chest. Follow-up from the patient's physician at the time revealed that the site would not provide any more information on the subjects. However, at a later date it was indicated that the patient had her generator removed due to "pain" in her axilla region, though a migration event could not be confirmed. Additional information from the patient's surgeon's office stated the patient "complained of pain in the axilla and numbness in the left arm from the generator when lying on her left side". Clinic notes from the neurologist indicated that he did not believe the vns was causing left arm numbness. Analysis on the returned generator showed that the septum was not returned, but no evidence of body fluids were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for further information have been unsuccessful to date.

 
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 Key2098578
Report Number1644487-2011-01123
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013476
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/28/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/21/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2005
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: 05/19/2011 Patient Sequence Number: 1
-
-