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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Device Problems Pin; Connection Problem
Event Date 09/01/2009
Event Type  Malfunction  
Event Description

During investigation in reference medwatch number: 1644487-2009-01743 for high impedance short circuit report x-rays were received for review. Manufacturer review of films noted the lead connector pin did not appear to be fully inserted into the generator connector block based on the view available. Based on the x-rays reviewed the appearance of the lead pin not being fully inserted could possibly be the cause of the high lead impedance, but a lead fracture cannot be ruled out. Surgical exploration has been planned for the patient on (b) (6) 2009. The patient in (b) (6) 2009 had high lead impedance that resolved in the or during their vns generator replacement and postoperatively was discovered to have high lead impedance again. The vns was programmed off.

 
Manufacturer Narrative

Manufacturer review of x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities noted. Appeared based on one view only, pin to not be fully inserted into the header of the generator.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1551036
Report Number1644487-2009-02641
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/05/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/23/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number103
Device LOT Number2349
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2009
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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