MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

Model Number 304-20

Device Problems Break (1069); Fracture (1260)

Patient Problem Pain (1994)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

During product analysis is was found that the explanted lead had a lead break.A coil break was identified in both the positive and negative lead coils.Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends.Secondary fractures were observed in at least two strands of the quadfilar coils.The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter.Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿.The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

• 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: 4202860
• MDR Text Key: 20297202
• Report Number: 1644487-2014-02836
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 304-20
• Device Lot Number: 3797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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: 25 YR