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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 Problems Seizures (2063); Ambulation Difficulties (2544)
Event Date 06/01/2020
Event Type  Injury  
Event Description
The patient has been experiencing an increase in falls as a results of her seizures which have gotten worse over the past 6 months.The physician has referred the patient to surgery for a generator replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Further information was received that the patient is not sure if her vns is still on and didn't see much of a benefit with vns.
 
Event Description
Patient underwent a battery replacement and the explanted device was discarded.
 
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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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key11094761
MDR Text Key224283685
Report Number1644487-2020-01750
Device Sequence Number1
Product Code LYJ
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 Physician
Type of Report Initial,Followup,Followup
Report Date 06/20/2022
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 Date11/21/2015
Device Model Number103
Device Lot Number202780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/07/2021
05/26/2022
Supplement Dates FDA Received02/01/2021
06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2014
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 Age52 YR
Patient SexFemale
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