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

Model Number 106

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

A patient underwent generator replacement surgery.Diagnostics on the explanted device were within the normal limits.The existing generator was then explanted, and the new generator was introduced into the field.The physician then used electrocautery to resize the pocket.The new generator was connected to the existing lead and high impedance was observed.The lead pin was removed and reinserted into the generator, and the high impedance message was observed again.The lead was then connected to the previous generator, and impedance was within the normal limits.The lead was then connected to the new generator and high impedance was observed again.A test resistor was then inserted into the new generator, and high impedance was observed during a generator diagnostic test.Finally, a third generator was connected to the lead, and normal impedance was observed.The third generator was implanted in the patient, and the generator displaying high impedance was returned to the manufacturer for analysis.Analysis has not been approved for the returned generator to date.The company representative present at the surgery confirmed that both the lead pin and test resistor pin were fully inserted into the generator each time the device was tested, and she noted that two clicks were heard, confirming that the setscrew had been tightened adequately.The company representative reported that the generator was not dropped at any time, but she was unsure if the electrocautery present in the field may have affected the performance of the generator.No additional relevant information has been received to date.

Event Description

The device history records were reviewed for the generator and indicated that the device met all specifications for release prior to distribution.Analysis was approved for the generator.Data was downloaded from the generator and reviewed.The programming history shows that only 2 diagnostic tests were performed on the date of surgery and indicates that the surgeon performed diagnostics with an incomplete connection between the lead and generator, and then interrogated the generator multiple times leading to the repeated high impedance warning messages observed during surgery.During analysis, various electrical loads were attached to the generator and diagnostic tests results demonstrated that accurate resistance measurements were obtained in all instances.The lead cavity was measured, and the dimensions met all specifications.The device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7177070
• MDR Text Key: 96824083
• Report Number: 1644487-2018-00056
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: 106
• Device Lot Number: 204163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2017
• 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: 35 YR