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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 09/02/2014
Event Type  Malfunction  
Event Description

It was reported that the patient moved states and has not been seen by a physician in 8 months. The patient reported that he feels a sensation in his chest area and is experiencing an increase in seizures. The patient was seen by a physician and device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred to surgeon. The patient underwent generator and lead replacement (including electrodes). The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Event Description

Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region. Some of the broken coil strands was identified as having pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening found on the outer silicone tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

 
Manufacturer Narrative

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

 
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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 Key4210932
Report Number1644487-2014-02882
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number302-20
Device LOT Number2004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/06/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2008
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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