MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

Uchida, d & yamamoto, t.(2017).Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients.No shinkei geka, 45(12):1051-1057.Doi: 10.11477/mf.1436203646.

Event Description

High lead impedance was observed during a system diagnostic test during an outpatient visit.The patient underwent lead and generator replacement surgery several months later to resolve the high impedance.The explanted lead and generator were returned to the manufacturer for analysis.Information received indicated that the physician contacted the distributor for an emergency revision surgery because the patient was complaining of painful stimulation in the neck.The physician then performed diagnostics and saw the high impedance warning.The physician suspected a lead fracture based on x-ray images.The cause of the fracture was believed to be due to generator twiddling by the patient.Further information received indicates that the patient could recognize the auras associated with his seizures and would try to stop the seizures using the magnet on his own; he sometimes groped the location of the generator, strongly grabbing it and moving it.The treating physician believes the patient's manipulation of the device is the cause of the suspected lead fracture.A photo of the explanted lead and generator showed clear evidence of patient manipulation of the implanted device.Analysis of the returned generator revealed no anomalies with the performance of the generator.The generator performed according to functional specifications.Analysis of the returned lead revealed no anomalies.A portion of the lead assembly, including the electrodes, was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, and no discontinuities were identified.The bilumen tubing appeared to be wavy in some areas and was returned in a coiled or twisted manner.An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between december 2010 and march 2016 was received several years after the event occurred.The abstract indicated that four patients experienced recurrent vocal cord paralysis.The abstract also indicated that one patient experienced subsequent aspiration pneumonia.Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture.The recurrent vocal cord paralysis is reported within mfr.Report # 1644487-2018-00123.A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr.Report #1644487-2018-00122.It was determined that the infections were previously reported to the manufacturer and are captured in mfr.Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368.The reported patient-influenced migration and subsequent lead fracture is captured within this report, mfr.Report # 1644487-2018-00289.Per the abstract, the patient revolved the generator underneath the skin, causing the lead fracture and necessitated vns explant.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7298219
• MDR Text Key: 100998708
• Report Number: 1644487-2018-00289
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 103
• Device Lot Number: 3494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR