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

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.

• 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 Key: 13118888
• MDR Text Key: 285618989
• Report Number: 1644487-2021-01850
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• 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 Date: 08/16/2023
• Device Model Number: 106
• Device Lot Number: 6953
• 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 Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/14/2022; 03/15/2022
• Supplement Dates FDA Received: 02/08/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female