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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 01/16/2015
Event Type  Malfunction  
Event Description

Additional information was received that the patient's vns system was still showing high impedance (impedance value >= 10,000 ohms) via diagnostic testing at the surgeon's office. The patient's vns was not programmed off. It was reported that x-rays were reviewed and no obvious lead fracture was observed, although the lead pin was seen to not be fully inserted past the connector block. It was reported that diagnostic testing showed normal results before, during, and after the patient's recent generator replacement surgery. Additional information was received that the patient underwent vns surgery (b)(6) 2015 to assess complete lead pin insertion. High impedance was stated to be confirmed via diagnostic testing on the old lead and generator. Pin re-insertion did not resolve the high impedance. Thus, a new lead was implanted and diagnostic testing again showed high impedance. Generator diagnostics was performed which showed proper generator functionality. The surgeon then reinserted the new lead while the hex screwdriver was inserted into the setscrew to relieve back pressure. This allowed for complete pin insertion and diagnostics then resulted in normal values. Thus, the lead replacement surgery resulted in successful resolution of the patient's high impedance. The explanted lead has not be received for analysis to date.

 
Event Description

Product information was obtained.

 
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The physician elected not to disable the patient¿s device following the high impedance observation. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

Device failure is suspected, 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 Key4502685
Report Number1644487-2015-03802
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number302-20
Device LOT Number8735
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/22/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2003
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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