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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

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CYBERONICS LEAD MODEL UNKNOWN Back to Search Results
Event Date 01/12/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2015 during review of the generator¿s programming history, it was observed that high impedance was seen on (b)(6) 2014. The patient identity is unknown. Good faith attempts for further information from the physician were unsuccessful.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL UNKNOWN
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
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 Key4528495
Report Number1644487-2015-03901
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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