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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Device Problem High impedance
Event Date 02/26/2014
Event Type  Malfunction  
Event Description

It was reported that the patient will be seen by ent for thyroid biopsy and evaluation and when that is complete the patient will be scheduled for generator and lead replacement. No surgical intervention has been performed to date.

 
Event Description

Additional information was received indicating that the vns patient¿s increase in seizures was below pre-vns baseline levels. The patient was seizure free since (b)(6) 2011. The patient was now having 12 seizures per day that were increasing in intensity and duration. The patient was referred for surgery but no known interventions have occurred to date.

 
Event Description

It was reported that the vns patient was experiencing and increase in seizures. The patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 9405 ohms). X-rays were provided to the manufacturer for review and the cause for the reported events could not be determined. There was a suspect area near the anchor tether which may be a possible break. There was nothing additional seen that would indicate there was any damage to the generator or lead. As the entire lead could not be assessed from the x-rays provided, continuity in that portion of the lead cannot be confirmed. Attempts for additional relevant information were made, but have been unsuccessful to date. No known interventions have occurred to date.

 
Event Description

Additional information was received that the explanted generator and lead were discarded and will not be returned to the manufacturer for evaluation.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a potential lead discontinuity. 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 surgery on (b)(6) 2014. The patient¿s generator was explanted, but the lead remained implanted due to concerns of potential damage to the patient¿s nerve. The explanted generator was discarded. A new generator and lead were implanted on the right side of the patient¿s body.

 
Event Description

Information was received indicating that an additional lead segment was explanted from a former abandoned lead during re-implant of a new left-sided lead in this patient on (b)(6) 2015 (see mfr report# 1644487-2015-05651). The lead was cut next to the nerve and the electrode coils remained implanted. The explanted lead segment was discarded by the explanting hospital. It was clarified that during the previously reported procedure on (b)(6) 2014 a segment of this same lead was explanted and discarded by the explanting hospital.

 
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Brand NameLEAD MODEL UNKNOWN
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 Key3705843
Report Number1644487-2014-00786
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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