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

Model Number 106

Device Problem Device Inoperable (1663)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes dated (b)(6) 2016 reported that interrogation of the patient's generator revealed "battery life less than 1/4.The generator device history record was reviewed and found all specifications were met prior to distribution.Through a review of the generator's internal data, it was found that the patient's device was set to a high duty cycle of 71% since (b)(6) 2015.From the only interrogation data available, dated (b)(6) 2016, the battery voltage was 2.824 v and the charge consumed was 17.284%.No additional relevant information has been received to date.

Event Description

Additional patient device data was reviewed from the physician's tablet data.No additional relevant information has been received to date.

Manufacturer Narrative

This information was inadvertently excluded from supplemental mdr 1.(b)(4) was inadvertently excluded from supplemental mdr 1.

Event Description

It was identified through an internal investigation that the observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths.This finding is indicative that the generator will reach true end of service earlier than expected.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's generator was at near end of service condition.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Patient underwent generator replacement and the generator was received.Analysis is underway but has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

The explanted generator was received and analyzed.An end-of-service warning message was verified in the product analysis (pa) lab and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.The pulse generator was most likely at a 25% indicator state and the high energy exposure resulted in further energy depletion from the battery.The battery was removed.The pcba was subjected to a postburn electrical tests and the results show that the pcba failed several electrical tests: supply current 2ma/normal, magnet detection normal, and magnet response.Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba.After the trimmed edge of the pcba was cleaned, a postburn electrical test was performed and the results indicate that only the magnet detection normal, and magnet response failed.These failures are due to the need for updates to the test software.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 and sensing conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation.

• 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: 6091353
• MDR Text Key: 59978114
• Report Number: 1644487-2016-02518
• 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,Followup,Followup,Followup
• Report Date: 01/04/2018

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: 08/20/2017
• Device Model Number: 106
• Device Lot Number: 203492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/28/2017; 11/17/2017; 12/14/2017
• Supplement Dates FDA Received: 12/08/2016; 12/15/2016; 10/23/2017; 12/11/2017; 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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: 19 YR