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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 04/23/2019
Event Type  Malfunction  
Event Description

Patient presented with high lead impedance upon interrogation. The battery was noted to be at ifi (intensified follow-up indicator). X-rays were received and reviewed for the patient. The generator was located in the patient¿s upper left chest. The connector pin can be seen coming through the second connector block. The filter feedthru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. A strain relief bend, strain relief loop, and one tie-down were present. The lead wires appeared intact at the connector pins. No sharp gross discontinuities were identified in the visible portion of the lead. A sharp angle was observed in the main body of the lead. Based on the x-rays received, the cause for the high impedance could not be determined. The presence of a fracture or micro-fracture in the lead cannot be ruled out. It should be noted that due to the scale of the images and the limited images provided, the complete length of the lead from neck to generator could not be assessed as the image was not provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8616027
Report Number1644487-2019-00941
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/08/2005
Device MODEL Number302-20
Device LOT Number009121
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2003
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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