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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL UNK
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LIVANOVA USA, INC. LEAD MODEL UNK Back to Search Results
Device Problem Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2021
Event Type  malfunction  
Event Description
It was reported that a patient's lead had an issue showing low impedance and was explanted.The lead is to be returned for analysis however has not been received for analysis to date.No additional relevant information has been received to date.
 
Event Description
The patient's lead was received into analysis.An identical report was found to house low impedance for this same patient implanted with the same returned lead serial number thus all incoming information will be added to and further reported under manufacturing report #: 1644487-2020-01351.
 
Manufacturer Narrative
Section d9.Device available for evaluation?; corrected data: device received into analysis prior to submission of initial mdr report however inadvertently not included.All further information to be reported in manufacturing report #: 1644487-2020-01351.
 
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Brand Name
LEAD MODEL UNK
Type of Device
LEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11425812
MDR Text Key238329643
Report Number1644487-2021-00323
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,foreig
Type of Report Initial,Followup
Report Date 04/06/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Event Location Other
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received04/06/2021
Supplement Dates FDA Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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