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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 09/29/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred to neurosurgery. No additional relevant information has been received to date.

 
Manufacturer Narrative

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

 
Event Description

It was reported that during surgery device diagnostics showed high impedance with the new generator attached to the existing lead. The generator was tested with the test resister which showed the generator was within normal limits. The surgeon then dissected the lead coils off of the nerve and placed a new lead. An implant card was received confirming that both the generator and lead were replaced and that lead impedance with the new system was within normal limits. The explanted lead was received for analysis. Analysis of the lead was completed on (b)(4) 2014. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution and surface contamination the fracture mechanism cannot be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Manufacturer Narrative

Device failure occurred, 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 Key4201101
Report Number1644487-2014-02828
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 09/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1080
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/27/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2005
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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