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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hiccups (1899); Depression (2361); Neck Pain (2433)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Patient reported pain in their neck at lead site when turning his head and bending down and also onset of chronic hiccups.There were no reports of fall or injury.A chest and neck x-ray were ordered and referral for a possible lead revision was noted.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Additional information received reporting that the discomfort with stimulation has caused the patient to feel depressed.
 
Manufacturer Narrative
B1.Adverse event or product problem , corrected data: initial report inadvertently did not mark product problem b2.Outcomes attributed to adverse event, corrected data: initial report inadvertently left blank b5.Describe event or problem , corrected data: initial report inadvertently left out details about the events reported.F10.Adverse event problem, corrected data: initial report inadvertently did not code 'e020202' and 'f0101' h1.Type of reportable event , corrected data: initial report inadvertently marked serious injury instead of malfunction.
 
Event Description
Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.After the replacement the patient was still experiencing hiccups and they have gotten worse.Once the patient taped the magnet over the device this resolved the issue.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key12263185
MDR Text Key264712660
Report Number1644487-2021-01047
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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 10/19/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date03/25/2019
Device Model Number106
Device Lot Number204163
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 07/08/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received08/26/2021
09/24/2021
Supplement Dates FDA Received08/26/2021
10/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
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