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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. 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 Hematoma (1884); Hemoptysis (1887); Post Operative Wound Infection (2446)
Event Date 09/08/2023
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.
 
Event Description
The patient reported that she had coughed up frank red blood.No other relevant information has been received to date.
 
Manufacturer Narrative
This report was due on november 25, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 20, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.
 
Event Description
Additional information received noting that the patient was admitted to the hospital for an emergency surgery due to an abscess at the throat surgery site.The patient was being treated with iv antibiotics and had an on and off fever with some white blood cell elevation.During the surgery, nothing abnormal was seen besides a hematoma that was cultured.The device was checked and the impedance was within normal limits.The cultures came back positive for staph aureus and the patient was sent home on keflex, which the staph had a sensitivity to.This resulted in the patient's neck incision is now more swollen and having some clear and blood drainage.
 
Manufacturer Narrative
H6 adverse event problem, corrected data: supplemental #01 report inadvertently did not code 'b01' for type of investigation and 'c19' for investigation findings.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key17945085
MDR Text Key325797045
Report Number1644487-2023-01482
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,Followup,Followup
Report Date 05/31/2024
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 Number7631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2023
Supplement Dates Manufacturer Received10/26/2023
Not provided
Supplement Dates FDA Received12/05/2023
05/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2023
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; Other;
Patient Age40 YR
Patient SexFemale
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