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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 08/08/2014
Event Type  Malfunction  
Event Description

X-rays were provided to the manufacturer for further review. Generator placement could not be assessed as a chest x-ray image was not provided. Lead pin insertion cannot be assessed due to the poor pixel resolution of the images provided. The filter feed-through wires appear to be intact. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem; corrected data: the previously submitted mdr inadvertently stated the x-ray images could not be assessed due to the quality of images. While a thorough assessment cannot be made, portions of the x-rays could be reviewed.

 
Event Description

It was reported that the vns patient's device showed high impedance. X-rays were provided but cannot be assessed due to the poor quality of the images. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Analysis of the returned lead portions was completed. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portions were performed and no discontinuities were identified.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4377881
Report Number1644487-2015-03512
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/05/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device MODEL Number103
Device LOT Number203017
Was Device Available For Evaluation? No
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2014
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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