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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 Problems Fatigue (1849); Hypoesthesia (2352); Neck Pain (2433)
Event Date 02/25/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that the patient had their generator replaced due to prophylactic reasons and the generator showing the "intensified follow up indicator".Further information was received that ever since the patient's seizures have stopped, the generator feels as if it is continuously stimulating (similar to magnet mode stimulation going off constantly).The patient was noted to be experiencing throat tightness, hoarseness, tingling of the head and generalized fatigue.This report is contained in manufacturing report number: 1644487-2021-00007.It was noted a similar issues occurred for the patient's first vns which required replacement (initially reported to be due to prophylactic reason).The patient's explanted device has not been received into analysis to date.No additional relevant information has been received to date.
 
Event Description
Information was received that per the physician the cause of the current present symptoms of continuous stimulation, painful stimulation (throat tightness), voice alteration, hypoesthesia, and fatigue are related to vns stimulation and "possibly" due to low battery (this report contained in manufacturing report number: 1644487-2021-00007) as the patient reported similar symptoms in 2015 when the generator battery life was at end of service.It was stated that per the physician, the current and previous battery replacements were performed in 2015 and 2020 due to the patient's report that he feels the vns device was/is firing abnormally, as if the magnet is being used constantly.Generators were both replaced for patient comfort and to preclude a serious injury.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 Key11109126
MDR Text Key224803272
Report Number1644487-2021-00006
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
Report Date 02/04/2021
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 Date10/30/2011
Device Model Number103
Device Lot Number2590
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received01/14/2021
Supplement Dates FDA Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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