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

Model Number 106

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intended m106 replacement generator was unable to detect the heart rate within surgery.A reading of ¿?????¿ was present in the heart rate field on all sensitivity settings.No pre-surgical evaluation was performed.Device diagnostics were within normal limits.The programmed currents were turned off during attempts to verify heart rate.All available sensitivity values were cycled through and the issue persisted.Recommendations were given to mitigate emi, to reposition in the pocket, and reposition the wand.A different generator was ultimately implanted without reported issue.The generator device history record was reviewed and found all specifications met prior to distribution.In particular, all functional specifications, including r-wave verification, were completed prior to distribution.The internal device data of the generator was reviewed.The three available lines of interrogation and diagnostics with the tachycardia detection enabled showed that a sensitivity setting of 5 was used.The detected foreground heart rate values were 81.2, 81.2, and 118.7 bpm.There were no anomalies with impedance or battery voltage noted.The suspect generator was received by the manufacturer on 06/13/2016 and is undergoing product analysis.

Event Description

Product analysis was completed on the returned generator on 07/07/2016.Review of the internal device data ¿sensecontrol¿ memory location showed that all tachycardia functions were enabled.External visual examination showed only observations consistent with the device explant procedure.Both interrogation and system diagnostic test were performed with expected results.The observed battery status was ifi=no.The pulse generator was placed in a final test fixture.A waveform generator setup was used for the basic stimulus to test the tachycardia detection feature.Heart beat sensitivity setting 5 was evaluated.The pulse generators sensing response showed sense delay starts of 17.8 seconds with a no load condition and 8.8 seconds with a 2k load condition.The pulse generator was opened.Possible contaminates were observed on the trimmed edge of the pcba (tab removed).The pulse generator module was subjected to a postburn electrical test.Results show that the pulse generator module failed several electrical tests associated with the identified contaminants.No additional pertinent information has been received to date.

• 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: 5735609
• MDR Text Key: 48742893
• Report Number: 1644487-2016-01395
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2017
• Device Model Number: 106
• Device Lot Number: 203469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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: 35 YR