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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 09/24/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc -7). The patient¿s device was not disabled following the high impedance observation. X-rays were taken and reported by the physician to be unremarkable. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The generator was replaced prophylactically. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Operative notes were received indicating that the vns patient¿s generator was tested with a test resistor and generator diagnostic results showed normal device function. 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 both positive and negative quadfilar coils in the electrode region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

 
Manufacturer Narrative

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

 
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 Key4207281
Report Number1644487-2014-02851
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 10/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number302-20
Device LOT Number008996
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/31/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/20/2003
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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