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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Event Date 08/10/2023
Event Type  Injury  
Event Description
It was reported that the patient will have to undergo surgery due to wound dehiscence and that their generator is to be explanted.Device history records were reviewed for the generator.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.Device evaluation is not needed as it will add no value to the investigation no known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
 
Manufacturer Narrative
H3.Device evaluated by mfr? code 81 - device evaluation is not necessary as it will add no value to the investigation.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 report of infection alongside wound dehiscence was inadvertently omitted in the initial report.No other relevant information has been received to date.
 
Manufacturer Narrative
F10.Corrected data, initial report: report of infection was inadvertently omitted in initial report.
 
Event Description
Additional information was received from the physician noting that the cause of wound dehiscence is due to poor wound healing due to malnutrition.The infection was assessed to be due to manipulation, poor hygiene and malnutrition.Device was noted to be explanted.No other relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 104
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key17655184
MDR Text Key322333484
Report Number1644487-2023-01229
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750047
UDI-Public05425025750047
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,Followup,Followup
Report Date 10/26/2023
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 Date02/23/2024
Device Model Number104
Device Lot Number7145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/10/2023
Initial Date FDA Received08/30/2023
Supplement Dates Manufacturer Received09/08/2023
10/03/2023
Supplement Dates FDA Received10/03/2023
10/26/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2022
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;
Patient Age30 YR
Patient SexMale
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