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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 03/03/2015
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for an end of service replacement that took place that day. The patient¿s generator prior to surgery was interrogated and showed ifi-yes. Diagnostics were also taken and resulted in a low impedance of <600 ohms. The patient was doing doing fine and has no increased seizures, so since the ifi=yes flag was seen they decided to replace before it actually gets to eos in case the seizures come back. Patient¿s programming history shows that the impedance has been dropping slowly since implantation suspecting a possible short circuit. The surgeon checked the lead and reported that he did not see anything obvious in terms of abrasions or fluid in lead at the area near the generator. He took out the old generator and replaced with a new generator. He performed the system diagnostics again and got high impedance at 9236 ohms. The surgeon re-inserted the pin and performed diagnostics which again showed a low impedance of <600 ohms. The surgeon performed two more diagnostic results which both showed low impedance but the surgeon decided to not revise the lead since he did not feel comfortable replacing it with just the diagnostic results. Patient was doing well prior to surgery so if there is an issue later on, he will bring them back into surgery. He informed the patient¿s family about his decision also. The explanted generator will not be returned for analysis.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4649309
Report Number1644487-2015-04335
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2006
Device MODEL Number302-20
Device LOT Number011537
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2004
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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