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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Event Description
Patient presented with high lead impedance and was referred for x-rays.The x-ray report indicated that the lead is continuous from the generator to the termination of the device at the base of the left neck.No discontinuity of the lead wire was seen.The x-ray images were not reviewed by the manufacturer.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
X-ray images were received and reviewed.The generator was located in the patient¿s upper left chest below the 5th rib.The connector pin cannot be seen coming through the second connector block.The notches on the lead pin that are usually in the middle of the two connector blocks when fully inserted, are closer to the first connector block.The filter feedthru were confirmed to be intact.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.A strain relief bend and loop were both present per labeling.The tie-downs being present and placed per labelling could not be assessed due to the quality of the images provided.There was a portion of the lead that appeared to be routed behind the generator.The lead wires are intact at the connector pins.No sharp angles were identified in the visible portion of the lead.The lead could not be fully assessed for gross fractures or discontinuities due to the quality of the images provided.The cause of the patient¿s high impedance is due to incomplete pin insertion.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.
 
Event Description
Additional information received noting that the patient underwent surgery and had their generator replaced.The surgeon did not try reinserting the lead pin as the patient's family requested the generator be replaced.All diagnostics tests with the newly implanted generator resulted in ok lead impedance.The explanted generator has not been received by product analysis to date.
 
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Brand Name
PULSE GEN MODEL 106
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 Key13118888
MDR Text Key285618989
Report Number1644487-2021-01850
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
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 04/08/2022
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 Date08/16/2023
Device Model Number106
Device Lot Number6953
Was Device Available for Evaluation? No
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 Received01/14/2022
03/15/2022
Supplement Dates FDA Received02/08/2022
04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2021
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 Age15 YR
Patient SexFemale
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