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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 Fatigue (1849)
Event Date 08/18/2020
Event Type  Injury  
Event Description
The patient reported to the rep that they having "aura after aura" and does not think their vns is working at all now.The physician increased the patients keppra to 3,000 mg/day and the patient is now exhausted.The physician noted that the patients fatigue is due to the low battery.Patients generator was explanted.The explanted generator has not been received by the manufacturer to date.No other relevant information has been received to date.
 
Event Description
Generator analysis was completed.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.653 volts (ifi range 2.60v - 2.80v) as measured during the final electrical test, shows an intensified follow-up indicator (ifi)=yes condition.The data in the diagaccumconsumed memory locations revealed that 103.054% of the battery had been consumed.
 
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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
MDR Report Key10523524
MDR Text Key206605761
Report Number1644487-2020-01197
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750030
UDI-Public05425025750030
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/20/2020
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 Date10/18/2015
Device Model Number103
Device Lot Number3801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Event Location Other
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received09/25/2020
Supplement Dates FDA Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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