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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302
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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2020
Event Type  malfunction  
Event Description
It was reported that the patient has high impedance and the device was disabled as a result.No known surgical intervention has occurred to date.No additional relevant information has been received to date.
 
Event Description
The patient's scheduled revision was cancelled by the surgeon as he deemed the procedure to risky due to the amount of scar tissue the patient had surrounding the lead.Therefore, at this time no surgery has occurred to date.
 
Event Description
Patient had a lead replacement performed.The explanted lead has not been received to date.No additional relevant information has been received to date.
 
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Brand Name
LEAD MODEL 302
Type of Device
LEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key10891243
MDR Text Key217996616
Report Number1644487-2020-01583
Device Sequence Number1
Product Code MUZ
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 09/24/2021
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 Date02/12/2010
Device Model Number302-20
Device Lot Number200421
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received12/18/2020
08/30/2021
Supplement Dates FDA Received01/11/2021
09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age76 YR
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