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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/27/2003
Event Type  Malfunction  
Event Description

This report is submitted to follow-up on the observation that the lead pin was not fully inserted into the generator as reported in mdr 1644487-2009-01703/1. Product analysis on the patient's explanted lead has been completed. During the analysis of the lead, no lead discontinuities were observed. It was noted by the impressions on the lead pin, that the lead pin was not fully inserted into the header of the generator during the time of implant. This condition would prevent electrical connection between the lead and generator, subsequently resulting in high lead impedance when diagnostics are performed thus indicating that the patient is not receiving vns therapy if the device was programmed on. However, despite good faith attempts to the treating vns physician, information regarding vns treatment including programming history data and efficacy was not provided to the manufacturer.

 
Manufacturer Narrative

Lead pin was not fully inserted into the header of the pulse generator.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1513222
Report Number1644487-2009-02287
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/24/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2003
Device MODEL Number102
Device LOT Number6393
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/16/2009
Is The Reporter A Health Professional? No
Date Manufacturer Received09/24/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2002
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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