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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Fracture (1260); Migration (4003)
Patient Problem Convulsion, Clonic (2222)
Event Date 06/21/2021
Event Type  malfunction  
Event Description
Patient's generator was found to be at eos and high impedance was observed.System diagnostics were unable to be performed as the generator was pulse disabled.It was reported that the patient was having several seizure due no longer receiving therapy from the battery depletion and high impedance.When opening the chest pocket during surgery, the lead was observed to have tears and kinks.When the generator was pulled from the pocket, the lead was seen to be completely severed.Per hospital policy, the explanted devices were discarded.No additional relevant information has been received to date.
 
Manufacturer Narrative
F10.- correction - f1905 & a010402 should have been included in initial mdr.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key12177496
MDR Text Key261826796
Report Number1644487-2021-00960
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
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 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/11/2016
Device Model Number304-20
Device Lot Number202308
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/15/2021
Supplement Dates Manufacturer Received08/10/2021
Supplement Dates FDA Received08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age29 YR
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