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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 01/08/2013
Event Type  Malfunction  
Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2013. High impedance was again observed on (b)(6) 2013 and (b)(6) 2014. Further follow-up revealed that the patient was seen for increased seizures and high impedance. X-rays were taken and showed a lead fracture. It was reported that the patient underwent lead replacement and is now doing well. It was reported that possible trauma caused the lead fracture although this could not be guaranteed. The device was not disabled after observing the high impedance as the patient did not show discomfort.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that the explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
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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 Key4541076
Report Number1644487-2015-03959
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number302-20
Device LOT Number1090
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2015 Patient Sequence Number: 1
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