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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 09/27/2013
Event Type  Malfunction  
Event Description

Preoperative device diagnostic testing for scheduled generator replacement surgery for end of service resulted in high impedance (dc dc code 7). The patient reported that he had experienced some neck "spasms"; several months prior and the physician turn the device settings down which seemed to alleviate symptoms. The surgeon programmed the generator off and cancelled the surgery. The patient will be rescheduled for generator and lead replacement. An implant card was received indicated that the patient underwent generator and lead replacement on (b)(6) 2013. The explanted devices have not been received for analysis to date. Attempts to obtain additional information have been unsuccessful to date.

 
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 Key3430851
Report Number1644487-2013-03319
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/27/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2013
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 Number011454
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2004
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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