• 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 103 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 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/25/2010
Event Type  Injury  
Event Description

It was reported that the patient was scheduled for a vns removal surgery. It was originally implanted for seizures and then she later learned she had pseudo seizures. The device was off for some time and she still had chest wall pain and when on stated her head was twitching. It was noted that the patient could not even tolerate mild stimulation. The physician reported that no causal or contributory programming or medication changes precede the onset of the head twitching and pain. He stated that he did not know if interventions were taken. He also stated that he didn¿t know the relationship of the head twitching and pain to vns. No manipulation or trauma occurred that is believed to have caused/contributed to the chest pain. He was also unable to provide the date of disablement. The patient¿s programming history was reviewed and the patient was disabled on (b)(6) 2010. Diagnostics were normal on that date as well.

 
Event Description

It was later reported that the patient had generator explant on (b)(6) 2015 due to pain and not having epileptic seizures. Vns was originally implanted for seizures and then she later learned she had pseudo seizures. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date.

 
Event Description

Although explant surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

Analysis of programming history.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the incorrect data. Date of event, corrected data: the initial report inadvertently reported the incorrect data.

 
Event Description

It was identified that the pin portion of lead was discovered in the generator header. Analysis has not been completed to date.

 
Manufacturer Narrative

Device available for evaluation, corrected data: the supplemental report #2 inadvertently did not report this data in this field.

 
Event Description

Lead product analysis was approved on 05/27/2015. The lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section was not returned; therefore, it was not possible to verify the model and serial number during this analysis, and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion 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 portion 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 portion of the device which may have contributed to the stated complaints. Generator product analysis was approved on 06/03/2015. In the (b)(4) lab, the device output signal was monitored for more than 24 hours, 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. The battery (2. 963 volts as measured during completion of electrical testing) shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
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 Key4609356
Report Number1644487-2015-04169
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number103
Device LOT Number201296
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/04/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/27/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2009
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: 03/17/2015 Patient Sequence Number: 1
-
-