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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Mechanical Problem
Event Date 08/31/2017
Event Type  Malfunction  
Event Description

It was reported that the surgeon opened a lead package for a new patient implant and was concerned about the way the lead coils looked. The surgeon thought something was wrong with the lead coil and felt the lead coils were fractured in the package and thus did not use it. A different lead was successfully used for the surgery. A review of device history records for the lead shows that no unresolved non-conformances were found. Analysis is underway but has not been completed to date.

 
Event Description

The lead underwent product analysis and a kink in at least one of the lead coils was noted past the electrode bifurcation. The anchor tether was also visualized to be torn into two pieces and the suture partially detached from the helix. Suspected tool imprints were identified on the anchor tether silicone helix near the tear. Though difficult to state conclusively based on the inspection results it is believed that the most likely root cause for the anchor tether suture detachment and the observed damaged to the anchor tether helix was manipulation of the lead not consistent with our labeling. Other than the above mentioned observations and typical implant or explant related observations, no other anomalies were identified in the returned lead assembly.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key6922020
Report Number1644487-2017-04540
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-20
Device LOT Number204071
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/03/2017
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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