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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

Analysis of the returned lead portions was completed on 02/27/2015 and it identified pitting on the pin surface; reddish deposits on the pin surface were found with a high percentage of iron that suggests that oxidation may have occurred, but the impact of this condition cannot be determined. No other anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. Analysis of the generator was completed on 03/04/2015 proper functionality of the pulse generator was verified. The device provided the expected level of output current. The battery showed an ifi=no condition. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred during replacement surgery on (b)(6) 2015, where the impedance value changed from high lead impedance to a normal limits range. No adverse conditions were identified for the generator.

 
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 for end of service. It was reported that device diagnostics in the operating room were within normal limits (2000 ohms). It was reported that the lead impedance increased gradually following surgery and that on (b)(6) 2014 the high impedance was first observed. It was reported that x-rays were scheduled and surgical revision was planned. No known surgical intervention has been performed to date.

 
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. Only a portion of the lead was returned for analysis which did not reveal any lead fractures. A lead fracture is suspected in the lead portion not returned.

 
Event Description

X-rays were taken and were reported by the physician to be unremarkable. It was reported that the patient underwent full revision surgery on (b)(6) 2015 to replace the lead. The generator was replaced prophylactically. The explanted devices were returned to the manufacturer. Analysis of the devices is currently underway.

 
Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the assessment of the x-rays by the health professional.

 
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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 Key4430709
Report Number1644487-2015-03660
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/23/2014
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 Date10/31/2011
Device MODEL Number302-20
Device LOT Number2205
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/27/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/07/2008
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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