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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 03/06/2024
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.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
It was reported that the patient is having their battery replaced due to an infection.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
 
Manufacturer Narrative
If explanted, give date; corrected information ; initial mdr inadvertently omitted information known prior to submission.
 
Event Description
Describe event; corrected information ; initial mdr inadvertently omitted information known prior to submission.
 
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Brand Name
PULSE GEN MODEL 103
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 Key19004183
MDR Text Key338912031
Report Number1644487-2024-00357
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750030
UDI-Public05425025750030
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/29/2024
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 Health Professional
Device Expiration Date02/11/2015
Device Model Number103
Device Lot Number202430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received03/29/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/06/2013
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 Age13 YR
Patient SexFemale
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