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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 Pocket Erosion (2013); Skin Infection (4544)
Event Date 03/19/2024
Event Type  Injury  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient was admitted into the hospital for a full revision due to the vns extruding from his chest.It was later reported that the patient underwent surgery and only a pocket revision was completed.Additional information received noting that the cause of the generator extrusion is due to wound dehiscence w/wound infection.Vns fully exposed in the chest wall.Per the physician, the believed cause of the wound dehiscence w/wound infection is patient manipulation.Device history records for the generator were reviewed.The generator was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications.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
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key19142197
MDR Text Key340569321
Report Number1644487-2024-00439
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/19/2024
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 Model Number1000
Device Lot Number206068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/02/2023
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; Required Intervention;
Patient Age51 YR
Patient SexMale
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