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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 10/23/2014
Event Type  Malfunction  
Event Description

It was reported that when the patient underwent a generator replacement due to end of service, when the new generator was placed interrogation showed a high lead impedance warning. No lead revision was performed at that time. Although surgery is likely, it has not occurred to date.

 
Event Description

Analysis of the lead was completed and confirmed the reported lead discontinuity. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil suggest a stress-induced fracture (fatigue) occurred in at least two strands of the quadfilar coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions occurred at the broken mate end. Due to mechanical distortion (smoothed surfaces) and/or metal dissolution, the fracture mechanism of the remaining strands cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Event Description

It was reported that the patient had lead replacement surgery on (b)(6) 2014 due to lead fracture. The lead was returned to the manufacturer for analysis. However, analysis has not been completed to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4251809
Report Number1644487-2014-03033
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 10/23/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number302-20
Device LOT Number200867
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/09/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2008
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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