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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 09/01/2016

Event Type  malfunction  

Event Description

It was reported that the patient¿s generator had reached the 25% indicator despite being at 100% battery life "about 3 months ago".The patient's husband and physician are concerned because the patient has demonstrated great benefit from the therapy but the she lives too far away for any increased follow-up.The husband mentioned he is dissatisfied with how quickly the battery has depleted.A review of device history records for the generator shows that no unresolved non-conformances were found.

Event Description

Additional decoder data was reviewed.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Based on this root cause and analysis of returned devices, the premature 25% battery life indicators are typically indicative that the generator will reach true end of service earlier than expected.A secondary cause for premature 25% battery life indicators in a small subset of associated generators may be high beginning of life (bol) battery impedance, and generators only affected by this secondary root cause would be expected to rebound back to normal battery life levels without any substantial programming changes.

Event Description

Additional programming data was received and analyzed.

Event Description

Patient's generator battery was reported to be completely dead.Patient underwent generator replacement.The explanted product has not been received to date.

Event Description

The explanted generator was received.Analysis is underway but has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

An end-of-service warning message was verified in the 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 reported allegations of ¿premature end of life (eol) 25% indicator¿ and ¿device failure¿ were duplicated in the lab.The battery was removed.The pcba (printed circuit board assembly) 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 the pcba passed the initially failed tests.Based on these 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.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for the pulsing mode 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: 6194043
• MDR Text Key: 62967694
• Report Number: 1644487-2016-02931
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/02/2017
• 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: 53 YR