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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problems Erratic or Intermittent Display (1182); Premature Elective Replacement Indicator (1483)
Patient Problems Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Event Description
Additional information was received that when high impedance was first seen, battery was ok however at following visits, the battery % fluctuated and is now at ifi with patient on rapid cycling.The fluctuating battery status is being reported in mfr report.The high impedance was already reported in mfr report # 1644487-2021-00143.No known surgery has occurred to date.No additional information has been received to date.
 
Manufacturer Narrative
B5.Event description ¿ correction ¿ inadvertently did not include in the initial mdr submitted.F10.Health effect ¿ clinical code ¿ correction ¿ inadvertently did not include in the initial mdr submitted.
 
Event Description
Additional information was received by the patient's caregiver that the patient was having ambulation difficulties they suspect to be related to the battery depletion.The event was also reported under mfr report #1644487-2021-00143 however will be reported and coded under this report as alleged to the battery depletion.No known surgery has occurred to date.No additional relevant information has been received to date.
 
Event Description
Patient has been referred for a full revision.No surgical intervention has occurred to date.No additional relevant information has been received to date.
 
Event Description
Additional information was received that patient underwent generator replacement.The patient¿s device showed end of service (eos) equals yes with pulse disabled along with high impedance.During surgery the surgeon removed the old generator and did not visually observe any issues with the generator or the lead.The replacement generator showed ok impedance.Pt's head was rotated right and left and diagnostics were checked to rule out micro-fractures with settings all showing normal.Lead was also pulled out as much as possible, diagnostics were checked, and settings were all normal.Lead left implanted with new generator.Pt was then closed, diagnostics were ran, and settings were all normal.The explanted device was sent to pathology.Explanted product has not been received to date.No additional relevant information has been received to date.
 
Event Description
Explanted product was received into product analysis.Product analysis was completed.The generator would not interrogate.The in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area passed.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block.The measure battery voltage confirmed eos condition.Other than the no communication (due to eos), the device performed according to functional specifications and there were no performance, or any other type of adverse conditions found with the pulse generator.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
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 Key13193899
MDR Text Key284356411
Report Number1644487-2022-00014
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
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 Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/09/2023
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 Date03/10/2022
Device Model Number1000
Device Lot Number205309
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/14/2021
Initial Date FDA Received01/07/2022
Supplement Dates Manufacturer Received02/01/2022
02/02/2022
05/17/2022
08/02/2022
12/19/2022
Supplement Dates FDA Received02/01/2022
02/02/2022
06/10/2022
08/26/2022
02/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
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 Age61 YR
Patient SexMale
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