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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 No Information (3190)
Event Date 07/30/2020
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized due to an unspecified adverse event.No additional relevant information has been received to date.
 
Manufacturer Narrative
B5.Describe event or problem - correction - generator replacement was inadvertently not included on supplemental #1.D7.Explant date - correction - explant date was inadvertently not included on supplemental #1.
 
Event Description
It was reported the patient had a generator replacement occur.The explanted device was discarded.No additional relevant information has been received to date.
 
Manufacturer Narrative
B2.Outcomes attributed to adverse event - correction - "required intervention to prevent permanent impairment/damage" and "other serious" options were not selected in the initial mdr.B5.Describe event - correction - information was not included in initial mdr.H6.Evaluation codes - method - correction - code 4117 was not coded in the initial mdr.
 
Event Description
It is unknown if the event is related to low battery or cardiac issue.No additional relevant information has been received to date.
 
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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 Key10535879
MDR Text Key207012764
Report Number1644487-2020-01211
Device Sequence Number1
Product Code LYJ
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,Followup
Report Date 11/06/2020
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 Date02/13/2016
Device Model Number103
Device Lot Number3884
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/15/2020
Supplement Dates Manufacturer Received10/09/2020
10/13/2020
Supplement Dates FDA Received10/09/2020
11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age66 YR
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