MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

The mdr with manufacturing number 1644487-2016-02574 captures the reported high impedance, change in seizure frequency, and change in seizure pattern.During the revision surgery on (b)(6) 2016 the surgeon opened the generator pocket first and noticed the plastic header of the 102r was completely disconnected from the generator canister.The generator was received for analysis on 12/05/2016.Product analysis is underway but has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the explanted generator and found that the header was completely detached from the can.There was no noted corrosion or body fluids observed in the detachment area, which means that the detachment occurred recently.Adequate adhesive residue was seen on the can in the header area.Visual observations did not show any tool marks on the can or header, which would indicate that the explant procedure was not the cause of the header detachment.Product analysis found that the header became detached during the implant period and not during the explant surgery.The generator was then altered to allow lead wires to connect to the circuit board and test the internal circuitry of the generator.There were no functional anomalies identified with the circuitry.Other than the detachment of the header from the can no anomalies were observed.

• Brand Name: PULSE GEN MODEL 102R
• 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: 6149605
• MDR Text Key: 62127203
• Report Number: 1644487-2016-02697
• 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
• Report Date: 01/24/2017

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: 06/30/2009
• Device Model Number: 102R
• Device Lot Number: 200618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2007
• 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: 36 YR