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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303
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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem High impedance (1291)
Patient Problem Pain (1994)
Event Date 02/01/2017
Event Type  malfunction  
Event Description
A patient's treating healthcare professional called stating that a patient was having discomfort with stimulation.The patient was seen in clinic and had an impedance increase of about 2,000 ohms, raising it to high impedance levels.No further relevant information has been received to date.
 
Event Description
During the review of the programming history database, additional programming and diagnostic data was identified for this patient.
 
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Brand Name
LEAD MODEL 303
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 Key6352516
MDR Text Key68114753
Report Number1644487-2017-03250
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number303-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received06/26/2017
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
Patient Sequence Number1
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