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

Model Number 106

Device Problem Failure to Sense (1559)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was difficulty detecting heart rate during initial implant surgery with a model 106 generator.No pre-surgical evaluation was performed.Sensitivity settings of 1-5 were tested, but it was only with settings 3 and 4 that would briefly give the correct heart rate (~60 beats per minute), but this would then turn to "?????" upon the heart rate detection display screen.It was noted that at setting 5 the device would show about triple the heart rate and then again revert back to "?????".Diagnostic testing showed the impedance was within normal limits.The green power light of the programming wand was noted to not be on for the full duration of testing.The 9v wand battery was changed and the wand power light stayed on for 25 seconds.After the wand battery was replaced, diagnostics were performed with an impedance 1251 ohms.The heart rate sensitivity was again tested at 3 and 4 but only showed "?????".It was confirmed that the green power light on the wand was on during the testing, but the data-receive light was not flashing with information on the heart rate per the physician.When the power light went out, the reset buttons were pressed to power up the wand, but this did not resolve the issue.No cautery was used near the generator during or after the generator was implanted.At this time, a back-up generator was implanted.Following implant of the back-up generator (implanted and tested in the exact same location with the same programming system), heart rate detection was performed without issue.The suspect generator has been received by the manufacturer for analysis but analysis has not been completed to date.Review of programming history shows that all output currents remained programmed off for the duration of surgery.Diagnostics were within normal limits (1293 ohms, 1195 ohms, 1251 ohms).In the course of surgery, sensitivity settings 1-5 were attempted.

Event Description

A user facility medwatch was received from the initial reporter ((b)(4)) stating that "the stimulator did not work properly.Device malfunction, that is, the device did not do what it was supposed to do." product analysis was completed on the opened but unused generator.Interrogation and system diagnostics test were performed, and results were as expected and within normal limits.To observe the pulse generators sensing response to an external stimulus, the pulse generator was placed in a final test fixture and setup.To use the tachycardia detection function of the tablet software (v11), the waveform generator setup was used for the basic stimulus.The stimulus (waveform generator) and pulse generator were connected to an oscilloscope for visual confirmation of pulse generator sensing the stimulus.Sense settings one through five were evaluated with a no load and 2k load condition.Various sense delay starts were observed (2.2 seconds to 18.4 seconds).The pulse generator was placed in a final test fixture and setup, and the sensing functions of the pulse generator were exercised: the sensing functions of the pulse generator performed according to functional specifications.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.In addition, the heartbeat detection test results that were documented during manufacture of the generator were retrieved to compare with those values obtained during analysis of the returned product.There were no appreciable differences in threshold detection levels between the two data sets.No additional relevant information has been obtained to date.

Event Description

Additional analysis of the generator was completed.The pulse generator was opened.Possible contaminates were observed on the trimmed edge of the pcb (tab removed).The pulse generator module was subjected to an electrical test.Results show that the pulse generator module failed several electrical tests.After cleaning the trimmed edge of the pcb with high grit sand paper and isopropyl alcohol to remove the suspected contaminates, the pulse generator performed according to functional specifications.The pulse generator was reassembled (with the original battery, case, and header).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 lasered edge of the pcb would have on the pulse generators sensing abilities.The pulse generator showed no sense delays (1.6 seconds to 2.6 seconds) after the lasered edge of the pcb was cleaned.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 (from initiation of the hb detection algorithm until hb synch pulses occur) 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 gain setting or location on the patient.Therefore, the allegation of under-sensing may have been verified.The removal of the tab from the pcb during the manufacturing process may have been the contributing factor for the reported allegation of ¿undersensing no r-wave detected¿.

• 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: 5127837
• MDR Text Key: 27846753
• Report Number: 1644487-2015-06015
• 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: Followup,Followup
• Report Date: 09/10/2015

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: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 106
• Device Lot Number: 144925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 79 DY
• Event Location: Operating Room
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2015; 01/01/2016
• 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: 52 YR