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

Model Number 106

Device Problem Device Inoperable (1663)

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

Event Date 08/04/2015

Event Type  malfunction  

Event Description

It was reported that a company representative was unable to obtain a heart rate reading from the generator that was being implanted in the patient.The implanting surgeon did not perform the pre-operative evaluation to determine if the placement of the generator was optimal to detect the patient's heart rate.System diagnostics were normal at the time the generator was implanted.Troubleshooting was performed, including changing the position of the wand and generator and adjusting the sensitivity setting, but the heart rate was still unable to be detected by the generator.The company representative noted that the loss of heart rate signal seemed to correlate with her moving around the patient in the operating room.The device history record was reviewed for the suspect device, and the generator passed all functional specification and electrical tests.Programmer data from the company representative's programming system indicated that no heart rate was steadily detected.The data from the physician's programming system was requested, but no relevant information has been received to date.

Manufacturer Narrative

Additional manufacturer narrative and/or corrected data, corrected data: initial report inadvertently left off udi of suspect device.Udi of suspect device: (b)(4).

Event Description

The programming data from the company representative's programming system was further reviewed, and the data showed that the generator did detect foreground heart rates, which were within the range that the company representative reported to be read off the heart rate monitor in the or.The patient has not scheduled a follow-up appointment with their treating physician to date, so no further data is available.

Event Description

Upon conclusion of the investigation of this event, it was determined that the cause of the undersensing was the movement of the programming system by the company representative during the implant surgery.The device functioned properly.

Event Description

The patient had generator replacement surgery due to premature battery depletion (reported in mfr.Report #1644487-2016-01943).Analysis of the generator identified that there were contaminates on the trimmed edge of the printed circuit board assembly (pcba), which was caused by the manufacturing method of removing the tab from the pcba.This was the cause of a delay in producing a heartbeat detection synch pulse.This synch pulse is received by the programming tablet and used to calculate the heartbeat rate.Test results of the synch pulse revealed a longer delay than what is expected.This was most likely the cause of the undersensing that occurred during the patient's implant procedure.

• 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: 5035033
• MDR Text Key: 25142329
• Report Number: 1644487-2015-05630
• 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: Followup,Followup,Followup,Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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: 11 YR