MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Difficult to Insert (1316); Sticking (1597); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Event Description

It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block.It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator.The grub screw was lost out of the head and both lead and generator had to be replaced.It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect.No further information was provided to date.

Manufacturer Narrative

Udi number: (b)(4).

Event Description

Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis.It was reported that when the reported issue was found, another device was implanted instead.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.

Event Description

The suspected generator and lead were returned to the manufacturer on 09/26/2016.An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed.The connector pin section including the small front o-ring and large o-rings was not returned.A portion of the connector boot was returned.The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure.No obvious anomalies were noted.Continuity checks of the returned portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest a product anomaly with the returned portions of the lead which may have contributed to the stated complaint.An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory.No obstructions were observed in the pulse generator header lead cavity or the connector blocks.The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0.136 inches minus (limits 0.137 +/- 0.002).The pulse generator header lead cavity, critical dimension 1, meets specification.In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016).The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016.This would suggest the lead pin was inserted into the pulse generator header.The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory.The septum was cored and damaged on the underneath side.This suggests that the setscrew was extracted up into the septum.This may be the contributing factor for allegation of "detachment of component(s) set screw".The pulse generator performed according to functional specifications.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 0.767% of the battery had been consumed.There were no performance or any other type of adverse condition found with the pulse generator.

Event Description

An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties.First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of.135 max, it may cause insertion difficulty.Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling.It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed.Review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: 5893260
• MDR Text Key: 53626777
• Report Number: 1644487-2016-01897
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2018

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: Health Professional
• Device Expiration Date: 05/24/2000
• Device Model Number: 303-20
• Device Lot Number: 300428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/22/2018
• Supplement Dates FDA Received: 09/19/2016; 10/17/2016; 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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: 44 YR