MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Difficult to Remove (1528)

Patient Problems Scar Tissue (2060); Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

It was reported that vns patient underwent lead revision surgery on (b)(6) 2015 due to lead discontinuity.The lead impedance value of the of the new vns system was within normal limits.Additional information was received from the physician that high lead impedance results was detected during follow up visit on (b)(6) 2014.The patient also mentioned that they noticed the vns stimulation was weak.Patient last felt normal stimulation in (b)(6) 2014.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.It was reported by the neurosurgeon that there was no obvious lead break visible on the explanted lead.Neurosurgeon noticed scars around the nerve and believes this can be the cause of the high impedance.It was reported that due to the scar, the lead was explanted in pieces and part of the lead probably remained under the scar which could not be removed.The explanting facility discarded the explanted device; therefore, no analysis can be performed.

• 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: 5144013
• MDR Text Key: 28473029
• Report Number: 1644487-2015-06071
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 09/15/2015

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 Expiration Date: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2005
• 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: 55 YR