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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 09/03/2014
Event Type  Malfunction  
Event Description

The unused lead was received for analysis. Analysis was completed on 02/10/2015. During the visual analysis the (+) white electrode ribbon appeared to be stretched and twisted and the helical appeared to be misshaped. What appeared to be remnants of dried body fluids were observed. The (-) green electrode ribbon appeared to be stretched and the helical appeared to be misshaped. What appeared to be remnants of dried body fluids were observed. The anchor tether helical appeared to be misshaped. What appeared to be specs of dried body fluids were observed. This most likely occurred due to manipulation of the lead during the attempted implant procedure while attempting to place the electrodes on the vagus nerve. Setscrew marks were not observed on the connector pin. The condition of the lead assembly returned is consistent with conditions that typically exist following an attempted implant procedure; therefore the absence of setscrew marks on the connector pin and abrasions on the connector boot and outer silicone tubing is evidence that the lead assembly was not fully implanted. No other obvious anomalies were noted. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.

 
Event Description

It was reported that during generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity, the vns patient¿s replacement lead was opened but not used. The surgeon stated that the opened lead was defective and could not be used as the middle helical could not be wrapped around the patient¿s nerve. Another lead was used to complete the procedure. The unused lead has not been returned to date. The lead discontinuity was reported in manufacturer report #1644487-2014-01204.

 
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Brand NameLEAD MODEL 304
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 Key4110329
Report Number1644487-2014-02429
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device MODEL Number304-20
Device LOT Number3886
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/23/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2014
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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