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

Model Number 106

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

Patient Problem No Information (3190)

Event Date 10/02/2015

Event Type  malfunction  

Event Description

It was reported that during initial implant surgery, the patient's new model 106 generator was unable to sense the patient's heart rate.Troubleshooting was performed by a company representative to attempt to resolve the issue.The wand battery was replaced, the wand was repositioned, the green power light was confirmed and it was confirmed that the device stimulation was off.Nothing resolved the issue.It was reported that no pre-operative ekg was performed due to surgeon preference; however, a new generator was used and this resolved the issue.The generator was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 12/01/2015.Sense settings one through five were evaluated with a no load and 2k load conditions between out2 and out1.The pulse generator showed typical sense delay response (1.8 seconds to 3.0 seconds).The pulse generator was opened.Possible contaminates were observed on the pcb trimmed edge of the pcb.With the pulse generator case removed and the battery still attached to the pcb, the supply current off-time (4.50ua) and supply current off-time sense enabled (7.00ua) measured at the pa bench were in specification (high limit for supply current off-time 5ua and high limit for supply current off-time sense enabled 8ua.The battery was removed.Results show that the pulse generator module performs according to functional specifications.The trimmed edge of the pcb was cleaned with high grit sand paper and isopropyl alcohol to remove the suspected contaminates.Sense settings one through five were re-evaluated with a no load and 2k load conditions between out2 and out1 to determine to what effect the removal of the contaminates from the trimmed edge of the pcb would have on the pulse generators sensing abilities.The pulse generator showed typical sense delay response (2.0 seconds to 3.0 seconds) after the trimmed edge of the pcb was cleaned.Test results of the synch pulse revealed a typical sense delay response from the generator.

Manufacturer Narrative

(b)(4).This information was inadvertently left off of previous mfr.Reports.

• 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: 5182086
• MDR Text Key: 30050813
• Report Number: 1644487-2015-06050
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2015

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: 05/13/2017
• Device Model Number: 106
• Device Lot Number: 4363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/10/2015; 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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: 26 YR