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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 Chest Pain (1776); Ecchymosis (1818); Hematoma (1884)
Event Date 10/14/2021
Event Type  Injury  
Manufacturer Narrative
Device return is not needed as the cause of the event is known and return would not add value to the investigation.
 
Event Description
It was reported that patient was rushed to the hospital after being hit in the chest over the vns device with a football.He was evaluated for swelling and given antibiotics.There is no redness and no temperature but swelling is the same and pain has increased.An update was provided that antibiotics were started and he has hematoma from contact injury.Doesn¿t want to drain and give a pathway for infection.Patient's mother provided more history that bully hit him in school on the device.Was seen in morning an device was working fine.Was then hit over device in afternoon football practice.No additional 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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key12796383
MDR Text Key280687659
Report Number1644487-2021-01561
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 Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/11/2021
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 Date05/06/2023
Device Model Number1000
Device Lot Number205568
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 10/18/2021
Initial Date FDA Received11/11/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/20/2021
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) Required Intervention; Other;
Patient Age9 YR
Patient SexMale
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