MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Failure to Reset (1532); Device Displays Incorrect Message (2591)

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

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi number: (b)(4).Initial reporter phone number: (b)(6).

Event Description

It was reported that a physician was unable to change a patient's settings.The patient had recently been implanted.Later follow-up found that the following message was identified when the generator was interrogated on (b)(6) 2016: vbatt < eos threshold.The device had been disabled (set to 0ma).The interrogation prior (on (b)(6) 2016) showed an expected value for the battery voltage.All diagnostics showed impedance values within normal limits.The patient had reportedly not undergone any surgeries and was not exposed to any electrical discharges between these two interrogations no known surgical intervention has occurred to date.

Event Description

Additional programming data was provided and did not show any indication of electrocautery usage during implant.The patient's generator was explanted on (b)(6) 2016 and was not able to be communicated with during surgery.The generator was reportedly sent for analysis, but has not been received to date.

Event Description

The generator was returned to the manufacturer and is currently undergoing product analysis.

Manufacturer Narrative

(b)(4).

Event Description

The generator had product analysis completed and it was unable to be interrogated and diagnostics were unable to be performed in the lab.Contaminates were identified on the trimmed edge of the printed circuit board assembly (pcba).The pcba was subjected to a postburn test where it failed several electrical tests.After the trimmed edge of the pcba was cleaned and the contaminates were removed, the pcba passed the postburn test and performed according to functional specifications.The battery voltage with the case removed and the generator battery attached to the pcba confirmed the end of service condition.

• Brand Name: PULSE GEN MODEL 105
• 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: 6064569
• MDR Text Key: 58815715
• Report Number: 1644487-2016-02514
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2017
• Device Model Number: 105
• Device Lot Number: 4356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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