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

Model Number 106

Device Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the patient was implanted with a model 106 device but the heart rate detection was not functioning.They tried every setting from 1 to 5, the surgeon re-opened the pocket and repositioned the generator and it still did not work.They tried swapping wands and tablets with no change.There was no pre-surgical evaluation performed because the physician has performed the surgery many times without problems.She stated the only abnormality she noticed with the generator is that the outer packaging was unsealed, though the inner packaging was uncompromised.She said they likely opened it to use on a patient, but realized they needed a different generator and decided to reuse the open generator since the inner packaging was still intact.The patient was then implanted with a different model 106 device which worked with setting 2.The surgery was completed with no further issues.The generator was received for analysis on 05/02/2016.Review of decoded data shows that on the date of implant ((b)(6) 2016) for the m106 generator sn: (b)(4), tachycardia detection was initially programmed off and then was turned on and sensitivity levels 1-5 were tested.Programming history is available from (b)(6) 2016.There is only one line of diagnostic data which shows that the device system diagnostics were within normal limits.The m106 device was kept at 0 ma output current and 0 ma magnet output current on this day.When tachycardia detection was first programmed on it was set to sensitivity level 1 and the foreground heart rate from the interrogation was 0 bpm.The sensitivity was tested at 3 with 60 bpm shown.

Event Description

Product analysis for the generator was completed and approved on 05/19/2016.The pulse generator was opened.A visual assessment on the pcba, performed at the product analysis test bench, showed possible contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.Both interrogation and system diagnostic test were performed, with a distance of one and one-quarter inches (spacer block) between the pulse generator and the programming wand.The following results were noted (load resistor/reported diagnostics results, all values in ohms and battery status): 4000/4000, with ifi no.Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed.To observe the pulse generators sensing response to an external stimulus, the pulse generator was placed in a final test fixture and setup.The stimulus (waveform generator) and pulse generator were connected to an oscilloscope for visual confirmation of pulse generator sensing the stimulus.The stimulus was connected to the pulse generator case and out2.Heart beat sensitivity setting two (as received) was evaluated with a no load and 2k load conditions between out2 and out1.The pulse generators sensing response observed in the lab showed sense delay starts of 29.8 seconds (plus sense drops out) with a no load condition and 2.6 seconds (plus sense drops out) with a 2k load condition (time of sense drop out 27.20 seconds).A comprehensive automated electrical evaluation showed that the pulse generator (in 'final' configuration) performed according to functional specifications.The pulse generator was opened.Possible contaminates were observed on the trimmed edge of the pcba (tab removed).The battery was removed.The pulse generator module was subjected to a postburn electrical test.Results show that the pulse generator module failed several electrical tests including the r2 verification, supply current 2ma/normal, supply current off, supply current off sense, magnet detection normal, magnet response and trim diagoncurrent.The pulse 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.Remaining residual material on the pcba edge after the 'test tab' removal manufacturing process may have been the contributing factor for the report of undersensing.

• 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: 5653077
• MDR Text Key: 46386675
• Report Number: 1644487-2016-01008
• 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: 04/18/2016

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: 05/20/2017
• Device Model Number: 106
• Device Lot Number: 4374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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: 24 YR