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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 01/06/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (5,000 ohms). It was reported that device diagnostics were within normal limits at the patient's previous visit in (b)(6) 2014. It was later reported that the device was programmed off and the patient was referred for x-rays. The patient's mother reported that the patient complained of feeling something moving in his neck approximately one month prior following a seizures. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that the patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator placement and high impedance. Pre-operative diagnostics showed normal impedance, although it was confirmed that diagnostics during the prior office visit showed high impedance at 5356 ohms. The surgeon also identified two visible breaks in the lead insulation during the surgery. The generator and lead replacement surgery was completed. 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 Key4452647
Report Number1644487-2015-03699
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 01/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number302-20
Device LOT Number1158
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/27/2005
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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