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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 High impedance (1291)
Patient Problem Seizures (2063)
Event Date 10/25/2019
Event Type  malfunction  
Event Description
It was reported that a patient's generator was interrogated and high impedance was detected.The patient also had a seizure after previously being well controlled.The patient was referred for surgery.No surgical intervention has occurred to date.No additional information has been received to date.
 
Event Description
Suspect lead product analysis was completed and approved.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Since a portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Explanted generator product analysis was completed and approved as well.An electrical evaluation showed that the device performed according to functional specifications.The battery showed an ifi=no condition.No additional information has been received to date.
 
Event Description
It was reported that the patient had a full revision.It was reported that during the revision, a new lead was implanted and tested with the previous generator.The previous generator tested with high impedance at this point, even after system diagnostics were performed and pin reinsertion was attempted.Once a new generator was connected to the new lead, the impedance was within normal limits.The generator and a piece of the lead were received for product analysis.Product analysis of the generator and lead has not been completed and approved to date.The high impedance that occurred when the previous generator was connected to the new lead is captured in mfr report #1644487-2020-00155.The high impedance that occurred before the lead revision is captured in this report.No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr?, data correction: selection of "yes" was inadvertently omitted in supplemental report #2.
 
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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
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 Key9532016
MDR Text Key183503758
Report Number1644487-2019-02524
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,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/26/2020
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 Date07/13/2006
Device Model Number302-20
Device Lot Number011040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/07/2020
02/06/2020
03/26/2020
Supplement Dates FDA Received01/31/2020
03/03/2020
03/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2004
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 Age26 YR
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