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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 High impedance (1291)
Patient Problem No Code Available (3191)
Event Date 06/10/2019
Event Type  malfunction  
Event Description
Patient's mother reported that she performed research and found cases were patients would experience device malfunction only when their heads were turned a certain way.The patient¿s mother then stated that she read a report about a specific patient where the wire was malfunctioning and even when the vns was turned off the patient continued to experience symptoms.According to the mother the report indicated that the symptoms only resolved when the lead was removed.No other relevant information has been received to date.
 
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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
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8753076
MDR Text Key149789628
Report Number1644487-2019-01260
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Event Location Other
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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