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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  malfunction  
Event Description
It was reported that a patient¿s device showed low lead impedance on diagnostics.The patient was referred for x-rays.The x-rays have not been received by the manufacturer to-date.The patient was referred for full revision surgery to replace the damaged lead and to replace the generator prophylactically.Additional relevant information has not been received to-date.No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred.The explanted devices have not been received by the manufacturer to-date.
 
Event Description
The explanted devices were discarded by the explant facility.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
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 Key6967346
MDR Text Key90290376
Report Number1644487-2017-04656
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/13/2016
Device Model Number304-20
Device Lot Number202308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 09/25/2017
Initial Date FDA Received10/20/2017
Supplement Dates Manufacturer Received01/12/2018
02/08/2018
Supplement Dates FDA Received02/05/2018
02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age17 YR
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