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

Model Number 106

Device Problems Detachment Of Device Component (1104); Premature End-of-Life Indicator (1480)

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

Event Date 09/13/2017

Event Type  malfunction  

Event Description

It was reported that the patient¿s device was explanted due to "battery near end of service, in the red".It was stated that the lead was not replaced.The explanted generator¿s header was detaching from the generator and it was unknown by the or specialist if this happened during surgery when the surgeon was removing the lead or if it was like this prior to surgery.It was reported that the surgeon was pulling with forceps to pull the generator out and was unsure if it happened prior to or during the explantation, but it did appear that she was using some force to get the battery out.They did not conduct system diagnostics prior to surgery and only interrogated the device to get old settings.It was also alleged that the m106 battery that was explanted depleted quicker than expected.The device history record was reviewed, and it showed that the device passed all specifications prior to release.The device was also laser-routed during manufacturing.Data from the generator was reviewed, which showed that the battery voltage was dropping more quickly than expected as compared to the amount of charge that had been consumed.This was most likely related to the laser-routing process during manufacturing, which is known to leave debris on the edge of the printed circuit board, thus providing a leakage path for current from the battery.The explanted generator was received for analysis and analysis is currently underway but not yet completed and approved.

Event Description

Product analysis for the generator was completed and approved on 10/17/2017.Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure.It is very likely that the header was detached from the pulse generator case during or after the explant process.This is based on the location of the tool marks observed on the pulse generator case.Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process.The pulse generator was opened.A visual assessment on the pcba, performed showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.During the bench interrogation, the pulse generator interrogated at a distance of one and one-quarter inches (spacer block) between the pulse disabled and eos warnings were set.The battery was removed.The printed circuit board assembly (pcba) was subjected to a postburn electrical test and results show that the pcba failed several electrical tests: r2 verification, supply current 2 ma/normal, supply current off, supply current off sense, magnet detection normal, magnet response, and trim diagon current.Fine grit sandpaper and isopropyl alcohol were used for the removal of the observed contaminates from the trimmed edge of the pcba.Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.No additional relevant 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: 6921975
• MDR Text Key: 89499751
• Report Number: 1644487-2017-04553
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: 106
• Device Lot Number: 4405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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: 18 YR