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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 07/11/2006
Event Type  Malfunction  
Event Description

Analysis of a generator explanted for end of service was completed on (b)(4) 2014. The supply current tests did not meet functional specifications. These measurements demonstrate an increased current consumption for the device, potentially contributing to a premature end of life condition. The increased current consumption was isolated to a leaky capacitor (c4). A battery life estimation resulted in 0. 48 years remaining before the eri flag would be set. However, an incomplete programming history indicates the estimation does not use all the data required to make an accurate estimation. With the capacitor substitution for c4, the pulse generator module performed according to functional specifications. The most probable root cause for the premature end of life condition was identified to be a leaky capacitor, c4. The cause for the c4 capacitors increase in leakage could not be determined.

 
Manufacturer Narrative

The generator was found to have a leaky capacitor, potentially contributing to a premature end of service condition.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3800932
Report Number1644487-2014-01227
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102R
Device LOT Number015709
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2014
Event Location Other
Date Manufacturer Received04/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/11/2006
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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