MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and diagnostic results reveal high lead impedance (dcdc ¿ 7).The patient¿s device was subsequently disabled.It was noted that the patient is cognitively impaired and requires ambulatory assistance mainly on the left side which the physician believed, along with the age of the device, was the cause of the high impedance condition.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance.The explanted generator and lead were received for analysis.When received, the generator's header was detached, but this was stated to have occurred during explant.Analysis of the explanted lead was completed.Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Analysis of the explanted generator has not been completed to date.

Event Description

Analysis of the explanted generator was completed.Visual examination confirmed that the header was detached from the pulse generator case, which is not typical in a surgical procedure.It is very likely that the header was detached from the pulse generator case during or after the explant process.This is based on the location of the tool marks observed on the pulse generator case and header.Other than the observed generator header detachment, there were no performance or any other type of adverse conditions found with the pulse generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

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

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4494144
• MDR Text Key: 5331234
• Report Number: 1644487-2015-03781
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

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: 06/30/1999
• Device Model Number: 300-20
• Device Lot Number: 23672C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/02/2015; 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/1999
• 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: 48 YR