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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 02/01/2018
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized due to tachycardia of about 180 bpm.The neurologist did not believe the increased heart rate correlated with the delivery of stimulation.The patient's normal and autostim output currents were programmed off on (b)(6) 2018.System diagnostics were reported to be normal.Of note, the vns was stated to be very efficacious for the patient.No additional or relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7664430
MDR Text Key113248965
Report Number1644487-2018-01147
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
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
Report Date 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2019
Device Model Number1000
Device Lot Number204232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received07/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2017
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 Outcome(s) Hospitalization;
Patient Age2 YR
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