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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE
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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 3000
Device Problems Computer Software Problem (1112); Improper Device Output (2953)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2018
Event Type  malfunction  
Event Description
It was reported that this patient was visiting the doctor¿s office and their autostim was turned off.The medical assistant had seen an error message but could not remember what it was.The patient was said to have been programmed with the m3000 programming software.No other relevant information has been received to date.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING SOFTWARE
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 Key7339779
MDR Text Key102443374
Report Number1644487-2018-00395
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750399
UDI-Public05425025750399
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 Physician
Type of Report Initial
Report Date 03/14/2018
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 Model NumberMODEL 3000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/14/2018
Initial Date FDA Received03/14/2018
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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