MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271); Neck Pain (2433)

Event Date 04/07/2010

Event Type  malfunction  

Manufacturer Narrative

Event Description

Clinic notes were received from a visit on (b)(6) 2015 indicating a patient was in referral to have his vns replaced due to the device reaching near end-of service.Device diagnostics were within normal limits on (b)(6) 2015.A call was later received on (b)(6) 2015 from a friend of the patient at their request stating that the patient was experiencing pain in his neck and he believes the device is trying to boost energy as the battery is about dead.It was reported that the feeling began that day after the neurologist visit.The physician had provided a new seizure medication until he can get the vns replaced as she had observed seizure activity at the visit.The generator was explanted on (b)(6) 2015.It was reported on (b)(6) 2015 that the reason for replacement was "unable to interrogate due to battery depletion".An estimate of battery life calculation was performed with the available history which estimated 6.5 years remaining until near end of service.However, the full history was not available in the programming database, and does not taken into account any programming changes since the last date of programming available, (b)(6) 2012, or magnet usage.The explanted generator was received and analysis was completed 01/14/2016.The reported failure to program was duplicated and measurement of the battery voltage determined that the battery was depleted.The supply current wait measurement did not meet the specification requirement.Analysis on the test bench identified and confirmed the c4 capacitor component as the root cause for the increased current drain.After the c4 capacitor component was cut out of the circuit and bridged with a known good bench c4 capacitor component, the generator module performed according to the functional specifications.The c4 capacitor leakage current demonstrated an increased current consumption for the device and potentially contributing to a premature end of the battery life.The reason for the c4 capacitor's increase in leakage current could not be determined.Review of the device manufacturing records revealed no anomalies during the manufacture of the device.The supply current tests, and all other tests met all specifications at the time of manufacture.No additional relevant information has been received to-date.

Event Description

A review of the manufacturer¿s in-house programming data showed additional information from 10/22/2015.On (b)(6) 2015, a system diagnostic was performed and resulted in a ¿fault¿ in communication.On (b)(6) 2015 the device was interrogated and the settings had been changed to unintended parameters.

• Brand Name: PULSE GEN MODEL 102
• 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: 5375108
• MDR Text Key: 36930777
• Report Number: 1644487-2016-00115
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: 102
• Device Lot Number: 2631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 37 YR