MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Seizures (2063)

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was reported to a company representative that a patient experienced an increase in seizures and had gone to the emergency department.At the emergency department the vns was interrogated and the physician notes indicated no issues with system diagnostics.Additional relevant information has not been received to-date.

Event Description

Full revision occurred.Normal impedance was reported at surgery.The battery was not at end-of-service.It was provided the generator will not be returned.It was noted in surgery the lead was twisted however, high impedance was not found.The explanted lead was received by the manufacturer.Analysis is underway, but has not been completed to-date.

Manufacturer Narrative

Date of event, corrected data: it was inadvertently not provided in follow-up report #1 that the date of the event was clarified to be (b)(6) 2017.

Event Description

Follow-up from the physician¿s office provided the vns was causing shocks and the shocking was then causing seizures to occur.The mother then wanted the whole device replaced.She stated that after the replacement, all has been well.It was stated that the vns had reduced seizures since being implanted and although more seizures were occurring they were not worse than before.Analysis was completed for the returned lead.The coil appeared to be stretched, kinked, wavy and spiraled, in some areas.The returned connector pin coil appeared to be broken and during the incision process several broken coil strands were observed.Scanning electron microscopy was performed and identified the area as having evidence of a rotational stress induced fracture with secondary break lines and no pitting.Residual material was observed on the coil surface.The analysis supports that the breaks occurred as a result of the explant process due to the rotational type of fracture on the broken coil wire surfaces and secondary break lines.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The set screw 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

• Brand Name: PULSE GEN MODEL 103
• 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: 6546464
• MDR Text Key: 74472104
• Report Number: 1644487-2017-03722
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2017

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: 07/12/2013
• Device Model Number: 103
• Device Lot Number: 201848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 06/09/2017
• Supplement Dates FDA Received: 05/30/2017; 07/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 24 YR