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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 11/10/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were taken and showed that the lead pin was not fully inserted into the generator header. X-rays were sent to manufacturer for review. Review of the x-rays confirmed that the lead pin did not appear to be fully inserted into the generator header. No other obvious discontinuities with the vns system were identified. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

 
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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 Key4317763
Report Number1644487-2014-03253
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number102R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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