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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 10/01/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that during a vns repositioning surgery for placement of a gastrostomy tube unrelated to vns, the surgeon pulled on the lead and it appeared to have broken while he tugged on it from its location at the upper incision. An implant card was also received indicating the lead was "fissured" during surgery when the lead was pulled back for repositioning. The generator was previously in the abdomen due to the patient's small size. The physician wanted to salvage the lead and replacement was not intended. They needed to re-tunnel for the lead so both incision sites were opened. The physician tugged the lead back, towards the neck. It was reported that the lead had frayed and broken near the lead pin and occurred while the physician was pulling on it very hard by hand. No surgical instruments were used on the lead. Diagnostics after the break were high. It was noted that the case was very difficult based on the patient铠size and complication due to the gastrostomy tube. It was reported that diagnostics were reportedly within normal limits prior to surgery. The generator was replaced as the battery was reported to be at near-end-of-service. The lead was discarded at the end of the procedure. The explanted generator has not been received to-date. No additional information has been received to-date.

 
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Brand NameLEAD MODEL 304
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5190183
Report Number1644487-2015-06238
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 10/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2017
Device MODEL Number304-20
Device LOT Number202593
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2013
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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