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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 06/07/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that high impedance was observed after the patient had her duty cycle increased on (b)(6) 2013 from 30sec on and 3min off to 30sec on and 1. 8min off. System diagnostics had been performed which showed a high impedance value of 7200ohms. When a subsequent system diagnostics test was performed the result was approximately 3000ohms and two more system diagnostics tests also showed the same results. No changes were observes or clinical manifestations and there were no falls or other trauma reported. It was stated that the patient is bed/wheelchair bound. The patient¿s current settings were noted to be output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time-1. 1min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. X-rays were performed and it was stated that there were no problems observed; they did not want to send them to the manufacturer for review. The device was left on. It was stated that the generator is located in the right side of the chest so the lead is positioned across the chest. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

 
Event Description

It was reported that the patient was seen on (b)(6) 2013 and diagnostics were fine.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2013 it was reported that the patient has not been seen yet by the physician.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3221239
Report Number1644487-2013-02077
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number302-20
Device LOT Number2086
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/19/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/02/2008
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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