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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 Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Event Description
It was reported that when opening up a replacement lead to implant, it was found that there was a damaged helical, so the lead was not used.Device history record for the lead was reviewed and showed the lead passed all specifications prior to distribution into the field.The lead has not been received for analysis to date.No other relevant information has been received to date.
 
Manufacturer Narrative
F10 adverse event problem, corrected data: initial report inadvertently listed wrong component code.H6 adverse event problem codes, corrected data: initial report inadvertently listed wrong investigation findings code.
 
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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 Key12120567
MDR Text Key259992814
Report Number1644487-2021-00917
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 07/29/2021
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 Health Professional
Device Model Number304-20
Device Lot Number205423
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received07/29/2021
Supplement Dates FDA Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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