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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 101; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 101; GENERATOR Back to Search Results
Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Scarring (2061)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient was referred for device explant due to the device disfiguring the patient resulting in the patient considering breast reconstruction surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Further information was received from the physician that the cause of the device disfiguring the patient's chest was the presence of the device and device location at the patient's nipple line.It was noted by the physician that the referral for device explant was for patient comfort only.Patient underwent generator explant surgery.
 
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Brand Name
PULSE GEN MODEL 101
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key9082373
MDR Text Key158997619
Report Number1644487-2019-01809
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 company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/17/2019
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 Date12/11/2002
Device Model Number101
Device Lot Number3535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 08/26/2019
Initial Date FDA Received09/18/2019
Supplement Dates Manufacturer Received09/23/2019
Supplement Dates FDA Received10/17/2019
Was Device Evaluated by Manufacturer? No
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 Age47 YR
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