MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302

Device Problems Break (1069); High impedance (1291)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on vns patient, the value was more than 7000 ohms.The patient was hospitalized for worsening of seizures.The physician referred the patient for x-rays.The x-rays were sent to the manufacturer for assessment.The review of the x-rays showed an obvious lead break on the wire close to the pin.A large portion of lead closed to the connector pin is coiled.Additional information was received that patient underwent full replacement surgery on (b)(6) 2016 due to high impedance/ lead break; the lead impedance retuned to the normal value after the surgery replacement, no explanted devices were returned to the manufacturer for the analysis as those were discarded after the surgery.It was also reported that before the replacement the seizures were worse than before the start of the vns therapy.The patient is discharged from hospital and doing well now.The review of the available programming and diagnostic history data did not reveal any anomalies.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 6137601
• MDR Text Key: 61503033
• Report Number: 1644487-2016-02758
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2016

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 Model Number: 302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/01/2016
• 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: 10 YR