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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 Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); No Code Available (3191)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's dad reported that the generator site is significantly warmer than the rest of her body.It was noted that the scar is healed and not red.It was noted that the patient was coughing a lot which would lead to choking, and she would became tachycardic (heart rate ~130 bpm) and would desat causing cyanosis.The dad would give her o2 until she would settle down.It was noted there was no fever or other signs of infection.Information was received from the nurse that autostimulation was causing the patient to cough which then caused heart rate elevation and caused the patient to desat.Autostimulation was disabled, and it was noted that the intervention was to preclude serious injury and for patient comfort.No other 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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key10852340
MDR Text Key216621392
Report Number1644487-2020-01541
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,consum
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2020
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 Date10/24/2021
Device Model Number1000
Device Lot Number205119
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 10/23/2020
Initial Date FDA Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2019
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 Age20 YR
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