MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Low impedance (2285); Material Twisted/Bent (2981)

Patient Problems Seizures (2063); Twiddlers Syndrome (2114)

Event Date 05/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A provider reported that a patient experienced a cluster of seizures for which the magnet successfully stopped on the first 3 seizures but was ineffective for the fourth seizures which reportedly lasted 10 minutes.The patient went to the emergency room and device interrogation revealed low lead impedance.X-rays were taken and submitted.X-rays show indicated of severe twisting of the lead consistent with patient manipulation of the implanted devices (twiddler's syndrome).Follow up with the provider indicated that they attribute the low lead impedance and lead twisting to patient manipulation (twiddler's syndrome).Prior device check information was not available but the provider indicated that all device checks prior to the most recent device check indicated normal device function.The provider did not know by which specific diagnostic test the low lead impedance was observed.The provider indicated that surgery has not been scheduled and that the surgery consult is pending.No known surgical interventions have occurred to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: the initial report inadvertently did not check adverse event.Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not check outcome for the adverse event.

Event Description

Although surgery is likely, no known surgical interventions have occurred to date.No additional relevant information has been reported to date.

Manufacturer Narrative

Date of event, corrected data: the initial report inadvertently reported this date incorrectly.The date should have been (b)(6) 2016.Date of this report, corrected data: the initial report inadvertently reported this date incorrectly.The date should have been 05/23/2016.Date received by manufacturer, corrected data: the initial report inadvertently reported this date incorrectly.The date should have been 05/23/2016.

Event Description

Clinic notes were received which stated that on (b)(6) 2016 the magnet aborted the patient's first three seizures however it did not abort the fourth.Therefore, the event date has been clarified.The notes also stated that the patient did not take her medication the day before or on the day of the cluster of seizures where the magnet did not abort the 4th seizure.It was reported that the patient is awaiting surgery to address the lead malfunction however no surgical interventions are known to have occurred to date.

Event Description

It was reported that the patient under went lead replacement surgery however the explanted lead was discarded by the surgical staff.Therefore product analysis will not be completed.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 5717527
• MDR Text Key: 48194450
• Report Number: 1644487-2016-01306
• 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,Followup,Followup
• Report Date: 05/23/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2019
• Device Model Number: 304-20
• Device Lot Number: 4380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/22/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 06/24/2016; 07/26/2016; 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR