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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL # 300

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CYBERONICS, INC. LEAD MODEL # 300 Back to Search Results
Model Number 300-20
Event Date 10/18/2012
Event Type  Malfunction  
Event Description

Additional information was received that on (b)(6) 2012 that the patient had a full revision surgery on (b)(6) 2012. No other information was provided at this time. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received that the lead was also returned to the manufacturer for evaluation. Product analysis is planned but has not been completed to date.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received that product analysis was completed on the generator and lead. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities 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. Note that since a large portion of the lead assembly (body) including the electrode array section.

 
Event Description

It was initially reported that the patient was having a full revision due to the generator being at end of service and the lead due to high impedance. The patient has been having an increase in seizures unknown if above or below pre-vns baseline. The physician felt that the seizures were due to both the high impedance and medication adjustments. There is no known trauma or manipulation that could have caused the issue. Surgery if likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.

 
Manufacturer Narrative

 
Event Description

Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

 
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Brand NameLEAD MODEL # 300
Type of DeviceLEAD
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2850997
Report Number1644487-2012-03141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/31/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/29/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2003
Device MODEL Number300-20
Device LOT Number3714
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/28/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/26/2001
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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