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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL UNK; GENERATOR
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LIVANOVA USA, INC. PULSE GEN MODEL UNK; GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Seroma (2069)
Event Date 04/26/2018
Event Type  Injury  
Event Description
A research article comprised of a long term follow-up study of vns patients.This report captures the deaths reported in the article.One patient was reported to have a seroma and another a hematoma around the battery.Both patient's were conservatively treated without further consequence.The reports of high impedance and increased seizures are captured in mfr report # 1644487-2018-01273.The reports of deaths are captured in mfr report # 1644487-2018-01272.
 
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Brand Name
PULSE GEN MODEL UNK
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
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7720056
MDR Text Key115020633
Report Number1644487-2018-01274
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 foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 07/25/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/28/2018
Initial Date FDA Received07/25/2018
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;
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