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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

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LIVANOVA USA, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problems Low impedance (2285); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Event Description
During a battery replacement upon dissection of the generator pocket, it was found that the generator was sitting on a calcified plate, exposing lead degradation.Once a new generator was implanted, low impedance was seen.Two days later the patient then underwent a full revision.The explanted products have not been received by product analysis to date.No other relevant information has been received to date.
 
Event Description
The explanted generator and lead were received but product analysis is still underway.
 
Event Description
Product analysis was completed on the returned generator and lead.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 3.055 volts, and the memory locations on the generator indicated that 3.471% of the battery had been consumed.There were no performance, or any other type of adverse condition found with the pulse generator.The lead analysis was completed but note that since a significant portion of the lead assembly (body) including the electrode array section was not returned for analysis, a complete evaluation could not be performed on the entire lead product.The reported low impedance was partially confirmed in the pa lab.A low impedance condition was identified due to exposed intertwined conductive coils, however that condition likely occurred during explant procedure.With the exception of the noted conditions above, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were identified in the returned lead portions.
 
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Brand Name
BIPOL LEAD MODEL 300
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key13122120
MDR Text Key285749228
Report Number1644487-2021-01852
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/02/2022
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 Date05/08/2000
Device Model Number300-20
Device Lot Number10987C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2022
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/14/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/07/2022
02/09/2022
Supplement Dates FDA Received02/01/2022
03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/1998
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 Age32 YR
Patient SexMale
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