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

Model Number 106

Device Problems Improper or Incorrect Procedure or Method (2017); Computer Operating System Problem (2898)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was having a m106 generator implanted on (b)(6) 2015.The physician and company representative were having issues while trying to detect a heart rate.The pre-operative evaluation was not performed prior to surgery.The generator was already implanted as far laterally as possible, and no one was touching the generator while communicating with it.The wand was confirmed to have a functioning battery, and they changed the wand position as well.The impedance was within normal limits, and the output current was off.While trying to detect a heart rate, the programmer showed ???? for about 25 seconds.The sensitivity was changed to 3.At that time a heart rate of 85 bpm was seen briefly, but then went to ????.Sensitivities 2 and 4 were tested, but only ???? were seen.The generator was then replaced, and the issue resolved.Programming data from the surgery was received, and a heart rate of 85 bpm was detected at sensitivity 5 by the generator.This corresponds to the heart rate seen on the programming system during surgery.Interrogation was only performed at sensitivity level 5 while tachycardia detection was on.Therefore, no data is available regarding heart rate detection for sensitivity levels 1-4.The generator was received on (b)(6) 2015, but analysis has not been completed to date.

Event Description

Analysis was completed on the returned generator on 12/10/2015.The sense settings were evaluated with various loads, and various sense delay starts and sense drop outs were observed.Once the generator can was opened, possible contaminates were observed on the trimmed edge of the printed circuit board (pcb).Multiple measurements were not within specification, and the generator failed several electrical tests.After cleaning the trimmed edge of the pcb, the generator performed according to functional specifications.The generator was reassembled, and the sense settings were re-evaluated.There were no sense delays.The generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse.This synch pulse is received by the tablet and used to calculate the heartbeat rate.Test results of the synch pulse revealed a longer delay than what is expected.This delay may have been interpreted by clinicians, as non-detection of a heartbeat signal, causing them to attempt detection at a different setting or location on the patient.The removal of the tab from the pcb during the manufacturing process may have been the contributing factor for the undersensing.

Manufacturer Narrative

Inadvertently left off which test was out of specification.

Event Description

Testing was consistent with the known manufacturing error identified.The supply current was out of specification.

• 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: 5247934
• MDR Text Key: 32261711
• Report Number: 1644487-2015-06556
• 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: 10/30/2015

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: 08/14/2017
• Device Model Number: 106
• Device Lot Number: 203490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/03/2016; 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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: 15 YR