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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 06/17/2017
Event Type  Malfunction  
Event Description

It was reported that the company representative was asked to attend a surgery she thought was only a generator replacement. However upon checking the device prior to surgery high impedance was observed. The lead and generator were then replaced. The explanted products have not been received to date. No additional relevant information has been received to date.

 
Event Description

The explanted lead and generator were received and are pending analysis. The lead's product information was identified following the explant. It indicated that the lead had been implanted for several years. A review of the diagnostic history from the internal database showed that impedance was within acceptable limits in the most recent history.

 
Event Description

Analysis was completed on the returned lead and generator. The generator case had scratches, tool marks and burn marks which are consistent with manipulation and exposure to electrocautery during the explant procedure. Upon interrogation the battery indicator was found to be ifi = yes. A series of interrogations and diagnostics were performed on the generator and the results were normal. During testing the generator performed to functional specification and passed electrical testing. The lead assembly was received in two pieces with the lead¿s pin still connected to the generator. The furthest electrode to the bifurcation was not returned for evaluation. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the set screw and the lead pin was present. Visual analysis of the lead completed for both lead segments. It was found that the lead was tangled and the outer tubing was abraded in the segment which included the lead pin. In both segments the lead coils were kinked and the electrode was noted to be damaged and partially detached, this was potentially related to the explant procedure. A fracture was identified in the lead coil in the lead assembly that was not attached to the lead pin and therefore not part of the continuity check. Pitting was observed at the point of fracture which indicates that the stimulation was being provided while the fracture was present.

 
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Brand NameLEAD MODEL UNK
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 Key7167569
Report Number1644487-2018-00021
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/15/2008
Device MODEL Number302-20
Device LOT Number1409
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2005
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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