• 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 03/07/2011
Event Type  Injury  
Event Description

It was initially reported that the patient was being explanted due to lack of efficacy. Further information was received that indicated that the patient was experiencing painful erratic stimulation and pain. The pain was believed to be due to the patient's significant weight loss due to a gallbladder infection, not related to vns, and the potential that the generator may have migrated. The patient went to see a surgeon and he disabled the device for a time but then turned it back to the previous settings with no additional reported issue. The plan is to continue with the generator replacement which as not occurred to date. The patient has also had an increase in nocturnal seizures, unknown if above or below baseline, which was treated with an increase in medication dose. At a later appointment it was reported that her seizures were doing well. Good faith attempts for more information have been unsuccessful to date.

 
Event Description

Additional information was received that indicated that the generator replacement was done prophylactically and for patient comfort as it was believed the painful stimulation was related to the generator nearing end of service. The patient is not having an increase in seizures. The patient reports that she is having an increase in seizures but the family and physician confirm that she is not. The patient is having more nocturnal seizures but they are within normal ranges of frequency and she does not consider it an increase. The patient had their generator replaced. Good faith attempts for product return are in process.

 
Manufacturer Narrative

 
Event Description

Additional information was received that indicated that the generator was returned to the manufacturer for evaluation. In the product analysis 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Follow-up report #1 inadvertently did not provide the explant date for the generator.

 
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2250798
Report Number1644487-2011-02189
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number013636
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/18/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/18/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/12/2004
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: 09/16/2011 Patient Sequence Number: 1
-
-