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

Model Number 1000

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 06/20/2019

Event Type  malfunction  

Event Description

It was reported that the patient's device has high impedance.It was also reported that the patient's voice is changing more than usual.The patient's device has been disabled.Device history records were reviewed for the patient's lead and the device passed all functional specifications and quality tests and were sterilized prior to distribution.Though surgery is likely, no surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received from a representative that per the patient's nurse, the physician's assessment of the high impedance is "a manufacturing problem in the lead or generator".The patient did not experience any trauma or falls at the site that could have caused a lead break.It was stated that the patient's voice alteration is occurring with during stimulation and no surgical intervention has been taken for the voice alteration.It was later reported that there are two different possible issues that caused the high impedance.It was stated that one possible cause was fibrosis between the lead and the electrode which increased the impedance from a normal lower impedance to a normal higher impedance.It was also stated that the lead pin is likely disconnected from the generator which caused the high impedance value.Ap and lateral chest x-rays were received and reviewed.Per the images received, the connector pin did not appear to be fully inserted, as the pin cannot be seen past the connector block.The placement of the generator is normal.The feed thru wires seem intact.The leads were located behind the generator and the lead wires at the connector pins appear to be intact.The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest.The lead and electrode site are not visible due to the scope and quality of the image and therefore strain relief and tie downs present cannot be assessed.It appears there is a loop present however cannot be confirmed.No gross fractures, discontinuities, or sharp angles were able to be visualized in the lead that was included in the image scope.Based on the x-rays received, the cause of the high impedance is appears to be due to incomplete pin-insertion.A possible microfrature in the part of the lead that was not able to be visualized in the x-ray images and also cannot be ruled out.No surgical intervention has been reported to date.No additional relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8798578
• MDR Text Key: 151307230
• Report Number: 1644487-2019-01379
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2020
• Device Model Number: 1000
• Device Lot Number: 5730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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: 44 YR