MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Failure to Interrogate (1332)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2019

Event Type  malfunction  

Event Description

It was reported that the vns m1000 generator was not able to be interrogated while in the sterile packaging.The programmer attempting to interrogate the generator was able to interrogate a demo generator and an additional generator in the same area without issue.Tablet troubleshooting was performed, but did not resolve the issue.An interrogation was also attempted outside of the or and the generator was still unable to be interrogated.The generator was allowed time to warm up for 30 minutes and was still unable to be interrogated.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.The suspect generator has not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

Generator product analysis completed.The failure to communicate was isolated to a malfunction of the asic.The cause of the malfunction was not determined and the component was sent to the vender for additional testing/analysis.The battery depletion was due to an excessive current drain caused by the asic malfunction.With the module connected to a power supply, the current drain was monitored using an amplifier.The device powered up properly with the exception of a high current drain.One second pulses at the end of the trace indicated that the processor was functioning.Initial interrogation of the generator using wandcomm revealed that the generator would communicate on the first attempt, but not on any additional interrogations.The module was reset, but did not resolve the issue.This was repeated multiple times.The asic was removed and tested on a breadboard, confirming that the malfunction was on the asic.Radiographic examination of the asic revealed no anomalies.Visual and radiographic examination of the device revealed no anomalies.

Manufacturer Narrative

Date of event, corrected data: initial report inadvertently listed (b)(6) 2019 instead of (b)(6) 2019.Describe event or problem, corrected data: initial report inadvertently left out information regarding product return and pending product analysis.Device available for evaluation?, corrected data: initial report inadvertently selected "no" instead of "yes" and listing "04/24/2019".Date received by manufacturer, corrected data: initial report inadvertently listed "(b)(6) 2019" instead of "(b)(6) 2019".Device evaluated by mfr?, corrected data: initial report inadvertently selected "not returned to mfr." instead of "no" and inputting the code "02".(b)(4).

Event Description

The suspect generator was received by the manufacturer and is pending product analysis.

Event Description

Prior to being sent to the vendor for additional testing/analysis, the component was misplaced and could not be sent to the vendor.

Manufacturer Narrative

B5, describe event or problem, corrected data: follow-up report #2 inadvertently stated "[¿] the component was sent to the vender for additional testing/analysis." instead of "prior to being sent to the vendor for additional testing/analysis, the component was misplaced and could not be sent to the vendor.".

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8584909
• MDR Text Key: 144279544
• Report Number: 1644487-2019-00868
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2020

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: Other
• Device Expiration Date: 01/29/2021
• Device Model Number: 1000
• Device Lot Number: 204805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Event Location: Other
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 07/15/2019; 05/13/2020
• Supplement Dates FDA Received: 06/13/2019; 08/07/2019; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1