MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported that during implant surgery, a generator was opened, but then not implanted because it was faulty.The manufacturer's device history records were reviewed.The suspect product passed all quality specification prior to distribution.No further relevant information has been received to date.The suspect product has not been received by the manufacturing facility to date.

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the surgeon that he believed the generator was faulty because once he tested the lead with the generator and unscrewed the set screw, the lead would not pull out of the generator.Instead the lead broke, making the generator unusable and leaving a portion of the lead in the generator.The generator and lead were received by the manufacturer.As received, the lead was attached to the generator.Product analysis was completed on the suspect generator.The reported removal difficulties were not duplicated during testing.No obstructions were observed in the header lead cavity or the connector blocks.In addition, the proper lead cavity dimensions in the header area were verified.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block and was removed with no issues.The generator met all product specifications.Product analysis has not been completed on the lead to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.The pin removal difficulties were not verified by product analysis.As received, the lead was returned in one portion and was still inserted in the generator.The set screw was extracted from the connector block.After the set screw was removed, the lead was reportedly removed from the generator with no physical resistance.Three sets of set screw marks were observed on the connector pin.The lead pin dimensions were within specifications.The connector boot was torn in half at the connector rings with the lead wires stretched between the halves.With the exception of the damaged connector boot, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 6360895
• MDR Text Key: 68411857
• Report Number: 1644487-2017-03252
• 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
• Report Date: 04/17/2017

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: 11/08/2018
• Device Model Number: 106
• Device Lot Number: 5115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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: 10 YR