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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 10/19/2018
Event Type  Injury  
Event Description
It was reported by the patient that they have a higher heart rate and their stomach feels like it's fluttering when they lay on their stomach or left side of their body.This has been occurring for the past two months.The patient wore a heart monitor but has not heard the results of the exam yet.Programming history was reviewed for the generator, and only was available on the date of implant.No programming anomalies were seen.Attempts for further information have been unsuccessful to date.No additional or relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
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 Key8239369
MDR Text Key132774571
Report Number1644487-2019-00038
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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 consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2019
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 Date07/17/2019
Device Model Number106
Device Lot Number204219
Was Device Available for Evaluation? No
Device Age14 MO
Event Location Other
Initial Date Manufacturer Received 12/19/2018
Initial Date FDA Received01/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
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) Other;
Patient Age37 YR
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