MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems Failure to Deliver Energy (1211); Device Expiration Issue (1216); High impedance (1291); Power Problem (3010)

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

Event Date 01/22/2008

Event Type  malfunction  

Event Description

It was reported that a vns patient underwent device replacement surgery on (b)(6) 2015.It was reported that the device was replaced due to end of service (eos).The explanted device was returned to the manufacturer on 04/28/2016.Analysis of the returned generator was completed and it appeared that the generator was received at the product analysis laboratory (pa lab) with an eos warning message and the output being disabled due to the generator remaining on after explant.Due to the high impedance and the generator remaining on after explant, a 'vboost' voltage was required which was higher than the maximum voltage capability for the generator.This is not considered a device failure, but is an expected event due to the generator remaining on after explant.The eos warning message was verified by the battery voltage (2.1v) and the data in the diagaccum consumed memory locations (85% of battery consumed).Furthermore a battery life calculation (blc) resulted in 2.3 years until near eos at time of explant.Since the generator remained on after explant, an extra blc was performed taking this into account.The generator had 0 years until near eos at the time it was received at the pa lab.The c4 capacitor was out of specifications.This decreased capacitance condition is an expected event for an aged capacitor of the type used for c4, as the manufacturing test limits for c4 value do not take aging into account.This condition does not indicate a failure of the device or the component, and is not expected to have an adverse effect on battery longevity.The supply current off-time test did not meet its functional specifications.This measurement demonstrates an increased current consumption for the device, potentially contributing to end-of-service.When the c3 capacitor was changed with another c3 capacitor, this problem no longer occurred.The cause for the capacitors (c3) increase in leakage could not be determined.The amount that the capacitor (c3) may have potentially contributed to end-of-service (eos) could not be determined; since the most probable root cause for the eos is the generator remaining on after explant.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5942440
• MDR Text Key: 54794941
• Report Number: 1644487-2016-02049
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2016

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: 01/31/2010
• Device Model Number: 104
• Device Lot Number: 200699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2008
• 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: 33 YR