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

Model Number 106

Device Problems Failure to Sense (1559); Device Stops Intermittently (1599)

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

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent implant surgery on (b)(6) 2015.Three system diagnostic tests (one out-of-pocket and two in-pocket) indicated normal results.Based on the pre-surgical ekg evaluation, heart beat detection was attempted at settings of 3, 4 and 5 and were not successful.Sensitivity levels 1 thru 5 were then attempted without success.With a few exceptions of heartbeat numbers being intermittently displayed, the only consistent display in the heart beat window was "?????" for all attempts.The green light on the programming wand was on during the detections step and there were only intermittent flashes of the orange "data received" light.The wand battery was replaced as a last step but did not resolve the issue.All troubleshooting steps were exhausted.Thus, a new m106 generator was connected to the lead and sutured into the exact same position as the previous generator.Heartbeat detection was verified almost immediately at a sensitivity setting of 3 and was within 1 bpm (at 54 bpm).The suspect opened but unused m106 generator has been received by the manufacturer for analysis.However, analysis has not been completed to date.Device manufacturing records were reviewed and found all specifications met prior to distribution.Programming data was reviewed for the patient and showed the following results for the foreground heart rate during interrogation, indicating that the generator was detecting the following heart rate values.Review of programming history shows that all output currents remained programmed off for the duration of surgery.In the course of surgery, sensitivity settings 1-5 were attempted.No additional relevant information has been obtained to date.

Event Description

Sense settings one through five were evaluated with a no load and 2k load conditions between out2 and out1.Various sense delay starts were observed (2.4 seconds to 26.4 seconds).The pulse generator was opened.Possible contaminates were observed on the pcb trimmed edge of the pcb (tab removed).With the pulse generator case removed and the battery still attached to the pcb, the supply current off (22.2ua) and supply current off sense (24.2ua) measured at the pa bench were not in specification (high limit for supply current off 5ua and high limit for supply current off sense 8ua).Results of the electrical test show that the pulse generator module failed several electrical tests.After cleaning the lasered 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, with the exception of the magnet detection normal and magnet response tests, which are due to the need for updates to the test software.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 (2.0 seconds to 3.0 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: 5196269
• MDR Text Key: 30525117
• Report Number: 1644487-2015-06312
• 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: Initial,Followup
• Report Date: 10/09/2015

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: 07/14/2017
• Device Model Number: 106
• Device Lot Number: 203424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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: 64 YR