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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 01/13/2020
Event Type  Injury  
Event Description
It was reported that the patient has been feeling tired and was wondering if it was due to the vns device.Information was received from the physician's office noting that the patient's fatigue is due to the patient's device not working.The nurse at the physicians office did not know if the referral for surgery was for patient comfort or to preclude a serious injury.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Patient generator was explanted.The explanted product was noted to have been discarded by the explant facility.
 
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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 Key9712090
MDR Text Key179456702
Report Number1644487-2020-00261
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 07/27/2020
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 Date05/01/2016
Device Model Number103
Device Lot Number202997
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 01/21/2020
Initial Date FDA Received02/14/2020
Supplement Dates Manufacturer Received07/02/2020
Supplement Dates FDA Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
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