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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 12/22/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the surgeon stated that the vns patient¿s lead may be fractured. Operative notes indicate that the setscrew was tightened appropriately and the replacement generator was tested with the existing lead. Diagnostic results consistently provided elevated impedance values. Pre-operative diagnostics could not be performed due to the end of service condition. The patient¿s generator was replaced and the procedure was completed with the device disabled. The patient was referred for lead replacement, but no known surgical interventions for the lead fracture. It was noted that the patient frequently has twisting and jerking neck movements which may have contributed to the lead fracture and that the patient has been having coughing fits.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015. Preoperative system diagnostic results showed high impedance (dcdc - 6). System diagnostic results with the replacement lead and existing generator showed lead impedance within normal limits (dcdc - 1). The surgeon confirmed that the lead had been completely and securely inserted into the generator header. It was noted that once the neck incision site was opened, it appeared that the anchor tether was out above the carotid sheath where the electrodes were implanted. The explanted generator and lead were returned to the manufacturer for analysis. There was no indication from the returned generator that an end of service or failure to program condition existed. The device communicated normally and performed according to functional specifications. No abnormal performance or any other type of adverse condition was found. Follow-up with the physician's office indicated that the programming system was working fine without any issues. Analysis of the returned lead confirmed discontinuity of quadfilar coil in the electrode region. Pitting was observed on the coil surface. Abraded openings of both inner tubes were observed near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes.

 
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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 Key4430479
Report Number1644487-2015-03656
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/22/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2012
Device MODEL Number302-20
Device LOT Number2340
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/22/2009
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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