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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 08/26/2014
Event Type  Malfunction  
Event Description

It was reported that during surgery for high impedance on (b)(6) 2014 (mfr. Report # 1644487-2014-01301), a new generator was connected to the lead which resulted in device diagnostics within normal limits (impedance value 3470 ohms). It was determined that the prior high impedance measurement was due to a lead pin insertion issue, so the existing lead was left in place. The next day, (b)(6) 2014, the patient's device was programmed on. System diagnostics were run, and the impedance was 2764 ohms. The patient was seen for follow-up on (b)(6) 2014. System diagnostics were performed, and the impedance was greater than 10,000ohms. It was advised that a likely intermittent lead fracture existed and the lead should be replaced. No known surgical intervention has been performed to date. No additional relevant information has been received 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 Key4164299
Report Number1644487-2014-02423
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/12/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number302-20
Device LOT Number1119
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/12/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2005
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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